Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters

[Find the meaning and references behind the names: Hardik, Prakash, Ama]

ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 64 Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters Hardik 1 , Apala Sengupta 2 , Chinky 3 1 Post Graduate Scholar, Department of Roga Nidana evum Vikriti Vigyana, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India. 2 Professor & HOD, Department of Roga Nidana evum Vikriti Vigyana, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India. 3 Post Graduate Scholar, Department of Panchakarma, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi, India I NTRODUCTION Prameha [1] is a disease existing from prehistoric era that is correlated with type 2 Diabetes mellitus, is affecting the 9.3% person of the world and 14% of India [2] As of 2014, an estimated 387 million people Address for correspondence: Dr. Hardik Post Graduate Scholar, Department of Roga Nidana evum Vikriti Vigyana, Institute of Post Graduate Ayurvedic Education and Research at Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, India. E-mail: hardiktaleja 1203@gmail.com Submission Date: 09/10/2024 Accepted Date: 17/11/2024 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.9.11.10 have diabetes worldwide, with type-2 diabetes making up about 90% of the cases. In classical text it had been highlighted that Amajirna [3] is the root cause to produce Prameha. In Amajirna [4] the incomplete or defective digestion caused due to influenced of vitiated Kapha within the stomach [5] As a result, Ama [6] is formed which vitiated consistency of Kapha and vitiate Meda. [7] The sequence of Meda Dushti ultimately originates Prameha. Acharya Sushruta has considered the Aparipakva (raw/not fully formed) Kapha as cause of Prameha while describing its pathogenesis [8] Acharya Dalhana has given the meaning of Aparipakva as Ama which proves that Prameha is caused by Amajirana [9] Acharya Charaka has also mentioned Prameha is caused by Amajirana which inturn caused by Kapha aggravating factors in the body [10] Agnimandya is caused due to the excess consumption of diet and lifestyle which aggravates Kapha which A B S T R A C T Background: In classical text it had been highlighted that Amajirna is root cause to produce Prameha . Musta is drug which combat Amajirna and it also effective to cure Prameha . So, this gives reasons for need of the present study and also reason for selection of topic. Aim: To evaluate the pathogenesis of Prameha from Amajirna and the efficacy of Musta ( Cyperous rotundus ) in both Amajirna and Prameha. Material and Methods : This study is an open label, randomized, interventional, comparative, prospective, controlled clinical trial. In the present study the patient of Prameha were enrolled following the subjective criteria of Prameha . A total of 60 patients of Prameha were selected from the OPD and IPD of Shyamadas Vaidya Shastra Pith Hospital, Kolkata, West Bengal, and randomly allocated with a computerized randomization method into two groups. Those selected patients were subjected for a confirmatory biochemical analysis of FBS and PPBS. The prediabetic person was interrogated for Amajirna as a past history or present illness, by the subjective criteria of Amajirna. In group A (n= 30), Musta Churna was given for 90 days and in group B (n= 30), Pippali Churna was given for 90 days. Before treatment and after treatment data FBS, PPBS, HBA 1 C, SGOT, SGPT, serum amylase, serum lipase and alkaline phosphatase enzyme levels were recorded for statistical analysis. This record of assessment was taken at 0, 30, 60 and 90 days. Wilcoxon signed rank test; unpaired t-test were applied Result: Both groups showed statistically significant (p<0.05) improvement in chief complaints of Prameha , Amajirna , FBS, PPBS, HBA 1 C, SGOT, SGPT, serum amylase, serum lipase and alkaline phosphatase. Conclusion: On percentage wise comparison, better relief was found in Group-A i.e., Musta Churna was found to be more effective in all the subjective and objective parameters than Group-B ( Pippali Churna). Key words: Prameha, Amajirna, Musta, Pippali

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 65 leads to Ama production in the body which is also called Dushit (impure) Kapha. [11,12] Till the time, Dushit Kapha remains in the abdominal area ( Koshtha ), is called Amajirna. Musta ( Cyperous rotundus ) is drug which combat Amajirna and it is also effective to cure Prameha . Hence a study was proposed here to verify the hypothesis on genesis of Prameha from Amajirna [13] and also evaluate to efficacy of Musta ( Cyperous rotundus ) in both the disease. For this purpose, patients were selected from institute of post graduate ayurvedic education and research in a randomized form. Efficacy of Musta was evaluated through statistical analysis. A IM To evaluate the pathogenesis of Prameha from Amajirna and the efficacy of Musta ( Cyperous rotundus ) in both Amajirna and Prameha. O BJECTIVES 1 To study the diagnostic approach of Prameha. 2 To explain the pathogenesis of Prameha from Amajirna. 3 To evaluate the efficacy of Musta ( Cyperous rotundus ) in both Amajirna and Prameha . M ATERIALS AND M ETHODS In the present study the patient of Prameha will be selected following the subjective criteria of Prameha . Those selected patients will be subjected for a confirmatory biochemical analysis of FBS and PPBS. The prediabetic state will be considered here, so the FBS and PPBS and HbA 1 c will range with in (100-125) mg/dl, (140-199) mg/dl, and (5.7-6.4)% respectively. The prediabetic person will be interrogated for Amajirna as a past history or present illness, by the subjective criteria of Amajirna. The objective criteria of Agnimandya i.e, hypo functioning. Agni will be verified through alkaline phosphatase etc. The selection of patients should do following the inclusion and exclusion criteria. The selected patient will be divided into two groups, Group A and Group B. Group A was treated with Musta ( Cyperous rotundus ) and Group B was treated with Pippali (piper longum). Group B was treated as control. The both groups were administered by the powder drug. The drug was administered in both the groups in divided doses per day. Before treatment and after treatment data of blood sugar level and enzyme level were recorded for statistical analysis. A complete history sheet was furnished as case report file (CRF). Study type Interventional, prospective, randomized, single blind, controlled clinical trial. Method of sampling Computer Generated Simple Randomized Method were followed Sample size 60 patients were taken for study (30 in each group) Study settings The study was conducted in OPD and IPD of the institute I.P.G.A.E & R at S.V.S.P hospital. The patients of Prameha were selected from the OPD through verification of subjective criteria. The selected patients were subjected for verification of subjective criteria. The selected patients were subjected for verification of objective criteria of biochemical investigation. During selection of the patient inclusion and exclusion criteria were strictly followed All details of the patients were recorded and maintained in the specially prepared proforma Before registering patients informed consent was taken. Group Design Group A - Musta Churna Group B - Pippali Churna (were treated as control) Before treatment and after treatment data of blood sugar level and enzyme level were recorded for statistical analysis. A complete history sheet will be furnished as case report file (CRF).

[Find the meaning and references behind the names: Luke]

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 66 Posology Details of dosage of Musta Churna and Pippali Churna Table 1: Plan of treatment protocol in Group A SN Name of Drug Dosage Form Dose & Frequenc y Time of administratio n & Anupana Duratio n 1. Musta Churn a Churna (Powder ) 3 gm twice a day Antebhakta (after food) with luke warm water orally 3 months Total Duration of Therapy 3 months Table 2: Plan of treatment Protocol in Group B SN Name of Drug Dosage Form Dose & Frequenc y Time of administratio n & Anupana Duratio n 1. Pippali Churn a Churna (Powder ) 3 gm twice a day Antebhakta (After food) with luke warm water orally 3 months Total Duration of Therapy 3 months Place of study Department of Roga Nidana Evum Vikriti Vigyana of Institute of Post Graduate Ayurvedic education and Research at Shyamadas Vaidya Sasthra Pith Hospital. 294/3/1, A.P.C. Rd, Kolkatta 09 Study population A small sample were taken from population those who are suffering from Prameha also presenting Amajirna , visiting the OPD and IPD, of I.P.G.A.E. & R at S.V.S.P Hospital. Sample size and design Sampling was done with a method of simple random sampling. The study was conducted with a target of at least 30-40 completed cases in each group. Since the trial medication will be given to only one half of the sample and the other will be treated as control group assuming maximum 30% drop out rate. This trans state will give a figure of approximately 80 subjects to recruit after screening to achieve the target sample size of not less than 0 in each group Inclusion criteria ▪ Adult subjects of either sex between 40-80 years of age. ▪ Presence of cardinal signs and symptoms of Prameha and Amajirna. ▪ Patients showing prediabetic stage, with an elevated blood glucose level ranging between FBS≥ {100- 125} mg/dl and PPBS≥ {140 -199} mg/dl and HBA 1 C ≥ {5.7 -6.4}. ▪ Biochemical assessment showing altered level of serum amylase, Serum lipase, aminotransferase (SGOT & SGPT), alkaline phosphatase to interpret on status of Agni. ▪ Patient those are not taking any type of medicine except research drug Exclusion criteria ▪ Diabetic stage. ▪ Pre-diabetic state with any complication. ▪ Dyspepsia due to any type of malignant condition. ▪ Dyspepsia where any type of surgical interference is necessary ▪ Pre-diabetic woman with pregnancy Study variables Respective relevant objective parameters of the disease are variables. Data collection & interpretation The drug was administered for 90 consecutive days for each patient for both the groups and were assessed after 90 days after the date of registration. The case report form was filled up in both the groups & the baseline parameter should be recorded. In both the groups, the following laboratory investigations were conducted during baseline & final follow up

[Find the meaning and references behind the names: Netra, Sita, Mala]

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 67 Schedule of data collection: In each group, the subject will be required at least 4 visits during studies Visit 1 - Screening & enrolment Visit 2 - First follow up (Day 30) Visit 3 - Second follow up (Day 60) Visit 4 - Final follow up (Day 90) Laboratory investigations ▪ FBS ▪ PPBS ▪ HBA 1 C ▪ Serum amylase ▪ Serum lipase ▪ SGOT ▪ SGPT ▪ Alkaline phosphatase All above mentioned investigation were performed before commencement of the treatment and after completion of the treatment Clinical parameters Screening criteria for Prameha [14] ▪ Swedanga - excessive sweating ▪ Anga Gandha - bad body odour ▪ Shithila Anga - Flabbiness of body ▪ Sahyya Ashana Prasukhe - sedentary lifestyle ▪ Ratischa - Ease of life ▪ Hrt Upadeha - heaviness in cardiac region ▪ Netra Jiva Shravana Upadeha - watering of eye tongue and ear ▪ Ghanangta - Obesity ▪ Kesha Nakha Ativriddhi - excessive growth of hair and Feet ▪ Shita Priyata - preference to cold ▪ Gala Talu Sosha - dryness of throat and palate ▪ Madhuryam Ashya - sweetness of mouth ▪ Kara Pada Daha - burning sensation of hand and feet ▪ Mutre Abhidhawanti Pippilika - swarming of ants in urine Screening criteria for Amajirna [15] ▪ Shotho Gandakshi Kutaga - swelling over eyes and cheeks ▪ Yatha Bhuktam Avidagdham Udgara - belching similar to those occurring soon after meal ▪ Utkleda - sensation of vomiting ▪ Mala Vata Apravritti ▪ Gourvam - heaviness in body/ abdomen Table 3: Screening criteria for Amajirna SN Clinical Features Finding Score 1 Shotho Gandakshi Kutaga None 0 Mild 1 Moderate 2 Severe 3 2 Yatha Bhuktam Avidagdham Udgara None 0 Mild 1 Moderate 2 Severe 3 3 Utkleda None 0 Mild 1 Moderate 2 Severe 3 4 Mala Vata Apravritti None 0 Mild 1 Moderate 2

[Find the meaning and references behind the names: Sama]

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 68 Severe 3 5 Gourvam None 0 Mild 1 Moderate 2 Severe 3 O BSERVATION AND R ESULTS Table 4: Agni wise distribution of patients SN Agni Total number of patients (n) Percentage (%) 1. Manda 31 51.67 2. Vishama 18 30.00 3. Tikshana 07 11.67 4. Sama 4 6.66 Total 60 100 It shows that 51.67% of patients had Mandagni, 34% of patients had Vishamagni , 11.67% patients had Tikshana Agni and 6.66% patients had Sama Agni . Figure 1: Showing Agni wise distribution of patients Table 5: Chief complaints wise distribution of Amajirna patients SN Chief complaints Total number of patients (n) Percentage (%) 1. Shotho Gandakshi Kutaga 37 61.67 2. YathaBhuktam Avidagdham Udgara 50 83.33 3. Utkleda 38 63.33 4. Mala Vata Apravritti 37 61.67 5. Gourvam 18 30.00 It shows that 83.33% of the patient had complaints of Yatha Bhuktam Avidagdham Udgara, followed by Utkleda in 63.33%, Shotho Gandakshi Kutaga and Mala Vata Apravritti in 61.67% and Gourvama in 30% of patients. Figure 2: Showing chief complaints wise distribution of Amajirna patients Table 6: FBS wise distribution of patients SN FBS (mmol/L) Total number of patients (n) Percentage (%) 1 ≥100 48 80 2 101- 125 12 20 Total 60 100 It shows that FBS level was found up to ≥100 mmol/L in 80% followed by 101- 125 mmol/L in 20% of the patients. Figure 3: Showing FBS wise distribution Table 7: PPBS wise distribution of patients SN PPBS (mmol/L) Total number of patients (n) Percentage (%) 1 ≥140 54 90.00 0 20 40 60 Manda Vishama Tikshana Sama Agni wise distribution of patients Total no. of patients Percentage (%) 0 50 100 Shotho gandakshi kutaga Yatha bhuktam avidagdham udgara Utkleda Mala Vata Apravritti Gourvam Chief complaints wise distribution of Amajirna Total number of patients (n) Percentage (%) 0 50 100 Total number of patients (n) Percentage (%) FBS wise distribution ≥100 101- 125

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 69 2 141- 150 4 6.67 3 151-199 2 3.33 Total 60 100 It shows that PPBS level was found up to ≥140 mmol/L in 90% followed by 141-150 mmol/L in 6.67% and 151- 199 mmol/L in 3.33% of the patients. Figure 4: Showing PPBS wise distribution of patients Table 8: HbA 1 c wise distribution of patients SN HbA 1 c (%) Total number of patients (n) Percentage (%) 1 ≥5.7 46 76.67 2 5.7- 6.0 13 21.66 3 6.1-6.4 1 01.67 Total 60 100 It shows that HbA 1 c level was found up to ≥5.7% in 76.67% followed by 5.7- 6.0% in 21.66% and 6.1-6.4% in 01.67% of the patients. Figure 5: Showing HbA 1 c wise distribution Table 9: Showing serum amylase wise distribution of patients SN Serum amylase (IU/L) Total number of patients (n) Percentage (%) 1 ≥100 36 60.00 2 101 - 200 23 38.33 3 >200 1 01.67 Total 60 100 It shows that serum amylase level was found up to ≥100 IU/L in 60% followed by 101 – 200 in 38.33% and >200 in 1.67% of the patients. Figure 6: Showing serum amylase wise distribution Table 10: Showing serum lipase wise distribution of patients SN Serum Lipase (IU/L) Total number of patients (n) Percentage (%) 1 ≥200 48 80.00 2 201 - 300 11 18.33 3 >300 1 01.67 Total 60 100 It shows that serum lipase level was found up to ≥200 IU/L in 80% followed by 201 – 300 in 18.33% and >300 in 1.67% of the patients. 0 50 100 ≥140 141- 150 151-199 PPBS wise distribution of patients Total number of patients (n) Percentage (%) 0 20 40 60 80 100 ≥5.7 5.7- 6.0 6.1-6.4 HbA 1 c wise distribution of patients Total number of patients (n) Percentage (%) 0 10 20 30 40 50 60 70 ≥100 101 - 200 >200 Serum amylase wise distribution of patients Total number of patients (n) Percentage (%)

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 70 Figure 7: Showing that Serum lipase wise distribution Table 11: Showing SGOT wise distribution of patients SN SGOT (units/liter of serum) Total number of patients (n) Percentage (%) 1 ≥50 48 80.00 2 51 - 150 12 20.00 3 >150 00 00 Total 60 100 It shows that SGOT level was found up to >150 units/litre of serum in 80% followed by 51 – 150 units/litre of serum in 20% and ≥50 units/litre of serum in 0% of the patients. Figure 8: Showing that SGOT wise distribution Table 12: Showing SGPT wise distribution of patients SN SGPT (units / litre of serum) Total number of patients (n) Percentage (%) 1 ≥60 40 66.67 2 61 - 150 20 33.33 3 >150 00 00 Total 60 100 It shows that SGPT level was found up to >150 units/litre of serum in 66.67% followed by 61 – 150 units/litre of serum in 33.33% and ≥60 units/litre of serum in 00% of the patients. Figure 9: Showing SGPT wise distribution Table 13: Showing alkaline phosphatase wise distribution of patients SN ALP (U/L) Total number of patients (n) Percentage (%) 1 ≥120 39 65.00 2 121 - 200 21 35.00 3 >200 00 00.00 Total 60 100 It shows that ALP level was found up to >200 (U/L) in 65% followed by 121 – 200 (U/L) in 35% and ≥120 (U/L) in 00% of the patients. Figure 10: Showing alkaline phosphatase wise distribution 0 50 100 ≥200 201 - 300 >300 Serum Lipase wise distribution of patients Total number of patients (n) Percentage (%) 0 20 40 60 80 100 ≥50 51 - 150 >150 SGOT wise distribution of patients Total number of patients (n) Percentage (%) 0 20 40 60 80 ≥60 61 - 150 >150 SGPT wise distribution of patients Total number of patients (n) Percentage (%) 0 20 40 60 80 ≥120 121 - 200 >200 Akaline phosphatase wise distribution Total number of patients (n) Percentage (%)

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 71 Effect of therapy on Objective criteria FBS Table 14: Effect of therapy on FBS Gro up Mean Value Diff. % Reli ef Paired “t” test BT AT S.D. S.E “t” p Signi. A 161. 76 143. 11 18.6 5 11.5 2 35.9 0 7.0 4 2.6 4 <0 .0 01 HS B 166. 86 146. 55 20.3 0 12.1 6 38.9 5 7.2 3 2.8 0 <0 .0 5 S It shows that, Group-A and Group-B showed 11.52% and 12.16% reduction in FBS respectively, which was statistically highly significant and significant respectively Table 15: Comparison of effect of therapy on FBS Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 18.65 35.90 7.04 1.1 <0.05 S B 20.31 38.95 7.23 It shows that, on applying Unpaired “t” test, the difference of decrease in FBS levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on FBS levels PPBS Table 16: Effect of therapy on PPBS Gro up Mean Value Diff . % Reli ef Paired “t” test BT AT S.D S.E. “t” p Signi . A 211. 26 184 .5 26. 76 18. 55 39. 90 7.8 2 3. 70 <0. 00 1 HS B 228. 75 186 .3 42. 44 12. 66 61. 75 11. 46 3. 42 <0. 05 S It shows that Group-A and Group-B showed 18.55% and 12.66% reduction in PPBS respectively, which was statistically highly significant and significant respectively Table 17: Comparison of effect of therapy on PPBS Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 26.76 39.9 7.82 2.6 <0.05 S B 42.44 61.7 5 11.4 6 It shows that on applying Unpaired “t” test, the difference of decrease in PPBS levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on PPBS levels. HbA 1 c Table 18: Effect of therapy on HbA 1 c Group Mean Value Diff. % Relief Paired “t” test BT AT S.D. S.E. “t” p Signi. A 7.8 7.6 0.20 20.34 0.81 0.16 4.44 <0.00 1 HS B 8.4 7.4 0.97 11.47 1.34 0.25 3.91 <0.05 S It shows that Group-A and Group-B showed 20.34% and 11.47% reduction in HbA 1 c respectively, which was statistically highly significant and significant respectively. Table 19: Comparison of effect of therapy on HbA 1 c Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 0.22 0.80 0.15 2.4 <0.05 S B 0.97 1.34 0.25 It shows that on applying Unpaired “t” test, the difference of decrease in HbA 1 c levels in both groups

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 72 was statistically significant. This indicates that both the drugs provided similar effect on HbA 1 c levels Serum amylase Table 20: Effect of therapy on Serum amylase Grou p Mean Value Diff. % Relief Paired “t” test BT AT S.D. S.E. “t” p Signi. A 25.99 25.30 0.69 18.30 5.98 1.17 4.35 <0.00 1 HS B 27.03 24.82 2.20 14.35 2.74 3.85 1.24 <0.05 S It shows that Group-A and Group-B showed 18.30% and 14.35% reduction in serum amylase respectively, which was statistically highly significant and significant respectively. Table 21: Comparison of effect of therapy on Serum amylase Grou p Differenc e in means Unpaired “t” test S.D. S.E. “t” p Significant A 0.69 5.9 8 1.1 7 1.2 3 <0. 05 S B 0.41 2.7 4 1.5 2 It shows that on applying Unpaired “t” test, the difference of decrease in serum amylase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum amylase levels. Serum lipase Table 22: Effect of therapy on Serum lipase Grou p Mean Value Diff. % Relie f Paired “t” test BT AT S.D. S.E. “t” p Signi. A 7.71 6.98 0.19 12.72 0.47 0.09 2.08 <0.00 1 HS B 7.09 7.02 0.06 10.98 0.41 0.07 1.34 <0.05 S It shows that Group-A and Group-B showed 12.72% and 10.98% reduction in serum lipase respectively, which was statistically highly significant and significant respectively. Table 23: Comparison of effect of therapy on Serum lipase Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 0.19 0.47 0.09 1.04 <0.05 S B 0.16 0.41 0.07 It shows that on applying Unpaired “t” test, the difference of decrease in serum lipase levels in both groups was statistically highly significant. This indicates that both the drugs provided similar effect on serum lipase levels. SGOT Table 24: Effect of therapy on SGOT Gro up Mean Value Dif f. % Reli ef Paired “t” test BT AT S.D. S.E “t” p Signi. A 41.3 8 33.1 3 8.2 3 19.8 41.0 9 8.0 5 4.4 5 <0. 00 1 HS B 27.0 3 24.8 2 2.2 0 8.13 20.7 4 3.8 5 2.0 2 <0. 05 S It shows that Group-A and Group-B showed 8.23% and 2.20% reduction in SGOT respectively, which was statistically highly significant and significant respectively Table 25: Comparison of effect of therapy on SGOT Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 8.23 41.09 8.05 2.45 <0.05 S B 2.13 20.72 3.84

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 73 It shows that on applying Unpaired “t” test, the difference of decrease in SGOT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGOT levels SGPT Table 26: Effect of therapy on SGPT Grou p Mean Value Diff . % Relie f Paired “t” test BT AT S.D S.E “t” p Signi . A 3.1 6 2.5 0.3 3 24.8 6 1.1 5 0.6 6 2.3 9 <0.00 1 HS B 1.4 4 0.6 5 0.7 9 10.4 4 1.7 8 0.3 3 1.3 4 <0.05 S It shows that Group-A and Group-B showed 24.86% and 10.44% reduction in SGPT respectively, which was statistically highly significant and significant respectively. Table 27: Comparison of effect of therapy on SGPT Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 0.19 1.66 0.32 1.28 <0.05 S B 0.79 1.78 0.34 It shows that on applying Unpaired “t” test, the difference of decrease in SGPT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGPT levels. Alkaline Phosphatase Table 28: Effect of therapy on Alkaline Phosphatase Gro up Mean Value Dif f. % Reli ef Paired “t” test BT A T S.D S.E “t” p Sign i. A 7. 8 7. 6 0.2 0 20.3 4 0.8 1 0.1 6 4.4 4 <0.0 01 HS B 8. 4 7. 4 0.9 7 11.4 7 1.3 4 0.2 5 3.9 1 <0.0 5 S It shows that Group-A and Group-B showed 20.34% and 11.47% reduction in alkaline phosphatase respectively, which was statistically highly significant and significant respectively. Table 29: Comparison of effect of therapy on Alkaline Phosphatase Group Difference in means Unpaired “t” test S.D. S.E. “t” p Significant A 0.22 0.80 0.15 2.4 <0.05 S B 0.97 1.34 0.25 It shows that on applying Unpaired “t” test, the difference of decrease in alkaline phosphatase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on alkaline phosphatase levels. DISCUSSION The subjective & objective parameter were assessed with data compilation & statistical analysis. The obtained data of before & after treatment of experimental group were evaluated through 't' test. The before treatment and after treatment value of blood glucose level and gastrointestinal enzymes level were computed to achieve 't' test and 'p' value by paired 't' test. The comparative study between Group A and Group B were done through unpaired 't' test. The obtained data of before treatment & after treatment were computed & analyzed statistically. The values are expressed as Mean ± SEM (Standard Error of Mean). The data were analyzed by paired ‘t’ test. A level of p<0.001 was considered as statistically highly significant and p<0.05 was considered as statistically significant. Comparative study of both Group - A & Group - B was done, through analysis of the obtained data by unpaired ‘t’ test. Level of significance was noted & interpreted accordingly.

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 74 Chief complaints of Amajirna It was observed that, 83.33% of the patient had complaints of Yatha Bhuktam Avidagdham Udgara, followed by Utkleda in 63.33%, Shotho Gandakshi Kutaga and Mala Vata Apravritti in 61.67% and Gourvam in 30% of patients. The above data supports the hypothesis that Amajirna is Kapha dominance Ajirna and if we recognize Amajirna from other type of Ajirna we can treat the disease according (Table 2). Blood sugar levels FBS level was found up to ≥100 mmol/L in 80% followed by 101- 125 mmol/L in 20% of the patients. PPBS level was found up to ≥140 mmol/L in 90% followed by 141-150 mmol/L in 6.67% and 151-199 mmol/L in 3.33% of the patients. HbA 1 c level was found up to ≥5.7% in 76.67% followed by 5.7- 6.0% in 21.66% and 6.1-6.4% in 1.67% of the patients (Table 3,4,5). Serum amylase level was found up to ≥100 IU/L in 60% followed by 101 – 200 in 38.33% and >200 in 6.67% of the patients. Serum lipase level was found up to ≥200 IU/L in 80% followed by 201 – 300 in 18.33% and>300 in 1.67% of the patients. SGOT level was found up to >150 units/litre of serum in 80% followed by 51 – 150 units/litre of serum in 20% and ≥50 units/litre of serum in 0.00% of the patients. SGPT level was found up to ≥60 units/litre of serum in 66.67% followed by 61 – 150 units/litre of serum in 33.33% and >150 units/litre of serum in 0.00% of the patients. ALP level was found up to >200 (U/L) in 65% followed by 121 – 200 (U/L) in 35% and ≥120 (U/L) in 0.00% of the patients (Table 6,7,8,9,10). Fasting Blood Sugar level Group-A and Group-B showed 11.52% and 12.16% reduction in FBS respectively, which was statistically highly significant and significant respectively. In diabetic state, there is beta cell failure leading to reduced basal insulin secretion in fasting state, drug showed fasting blood sugar lowering effect which is statistically significant in both the groups. It shows possibility of beta cell protective or regenerative effect of drugs (Table 11). Post Prandial Blood Sugar level Group-A and Group-B showed 18.55% and 12.66% reduction in PPBS respectively, which was statistically highly significant and significant respectively, this may be because of retarding the carbohydrate absorption from intestine, α - glucosidase inhibitor action & improvement in peripheral glucose uptake (Table 13) Serum HbA 1 c Group-A and Group-B showed 20.34% and 11.47% reduction in HbA 1 c respectively, which was statistically highly significant and significant respectively (Table 15). On applying Unpaired “t” test, the difference of decrease in HbA 1 c levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on HbA 1 c levels (Table 16). Serum amylase Group-A and Group-B showed 18.30% and 14.35% reduction in serum amylase respectively, which was statistically highly significant and significant respectively (Table 17) On applying Unpaired “t” test, the difference of decrease in serum amylase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum amylase levels (Table 18). Serum lipase Group-A and Group-B showed 12.72% and 10.98% reduction in serum lipase respectively, which was statistically highly significant and significant respectively (Table 19) On applying Unpaired “t” test, the difference of decrease in serum lipase levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on serum lipase levels (Table 20). SGOT Group-A and Group-B showed 8.23% and 2.20% reduction in SGOT respectively, which was statistically

[Find the meaning and references behind the names: Guna, Rasa, Anusha, Good]

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 75 highly significant and significant respectively (Table 21). On applying Unpaired “t” test, the difference of decrease in SGOT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGOT levels (Table 22) SGPT Group-A and Group-B showed 24.86% and 10.44% reduction in SGPT respectively, which was statistically highly significant and significant respectively (Table 23) On applying Unpaired “t” test, the difference of decrease in SGPT levels in both groups was statistically significant. This indicates that both the drugs provided similar effect on SGPT levels (Table 24) Alkaline phosphatase Group-A and Group-B showed 20.34% and 11.47% reduction in alkaline phosphatase respectively, which was statistically highly significant and significant respectively (Table 25) This can be inferred that existing duration of therapy have significant role on FBS, PPBS, HbA 1 c, serum amylase, serum lipase, SGOT, SGPT, Alkaline phosphatase level. Comparative Effect of Therapy Effect on Chief complaints In Group A, Shotho Gandakshi Kutaga was relieved by 76.50% which was statistically highly significant (p  0.001), while in Group B it was relieved by 58.82% which was statistically significant (p  0.05) In Group A, Yatha Bhuktam Avidagdham Udgara was relieved by 88.02% which was statistically highly significant (p  0.001), while in Group B it was relieved by 41.17% which was statistically significant (p  0.05) In Group A, Utkleda was relieved by 80.64% which was statistically highly significant (p  0.001), while in Group B it was relieved by 32.50% which was statistically significant (p  0.05). In Group A, Mala Vata Apravritti was relieved by 80% which was statistically highly significant (p  0.001), while in Group B it was relieved by 33.33% which was statistically significant (p  0.05). In Group A, Gouravam was relieved by 78.37% which was statistically highly significant (p  0.001), while in Group B it was relieved by 55.10% which was statistically significant (p  0.05) (Table 6.29). The above data supports the hypothesis that Amajirna Prameha is Kapha dominance Ajirna and if we recognize Amajirna from other type of Ajirna we can treat the disease according. Musta churna show good result because Katu, Tikta and Kashya Rasa , Laghu and Ruksha Guna , Sheeta Virya and Katu Vipaka gives Kaphapitta Shamana effect and as it is having Katu Rasa, Laghu Guna , it increases the Agni and also give Kapha Shamana, Deepana, Pachana, Rochana , Ama hara and Lekhana properties. Hence the relief observed was higher and statistically highly significant. On the other hand, Pippali Churna due to its Katu Rasa, Laghu Snigdha and Tikshna Guna, Anusha sheeta Virya, Madhura Vipaka and Vatakaphashamaka Doshaghnata. Due to these qualities, it helps in relieving Amajirna Prameha. Hence the relief observed was statistically significant. Statistically all Amajirna Prameha Lakshana show highly significant result due to the Agni Deepana , Ama Pachana Premehahara action of, Ama was disappeared and hence the symptoms of Amajirna Prameha got relieved. Overall effect of therapy In Group A, marked improvement was observed in 83.33% of the patient, moderate improvement was observed in 16.67% of patients. In Group B, marked improvement was observed in 60% patients, moderate improvement was observed in 33.33% patients and mild improvement was observed in 6.67% patients. No patients were observed as complete cured and unchanged in both the groups. CONCLUSION Amajirna Prameha (Pre-Diabetes) with dominancy of Kapha among the Doshas, Meda among the Dooshyas . Both the groups were having statistically significant result in the parameters i.e., FBS, PPBS, HBA 1 C, SGOT, SGPT, serum amylase, serum lipase and alkaline

[Find the meaning and references behind the names: Shri, Sharma, Ram, Murthy, Shah, Sah, Madhav, Bhagwan, Siddharth, Nil, Med, Karan]

Hardik et al. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters ISSN: 2456-3110 ORIGINAL ARTICLE November 2024 Journal of Ayurveda and Integrated Medical Sciences | November 2024 | Vol. 9 | Issue 11 76 phosphatase. But in inter group comparison, Musta Churna was found to be more effective than Pippali Churna. There is further scope for new researchers to used formulation containing more drugs instead of single drug. The present work could be conducted with large sample size and more days of drug given which might give better results REFERENCES 1 Dr. Ram Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita Text with English translation & critical exposition based on chakrapani dutta Ayurveda dipika, Chowkhamba Sanskrit Series office. Varanasi, Vol-3, edition reprint-2014, chapter-6, Shloka no 51 to 54, page no 13-14. 2 API Textbook of Medicine edited by Siddharth N. Shah, Publised by THE Association of Physicians of India, 7 th edi., revised reprint 2006. 3 Dr. Ram Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita, Text with English translation & critical exposition based on chakrapani dutta Ayurveda dipika, Chowkhamba Sanskrit Series office, Varanasi, Vol -2 edn reprint-2013, Chap- 8 shloka- 16,17 page no. 105 4 Acharya Shri yadyunandan Upadhyay, shri vijyarakshit, madhav nidanam madhukosh vyakhya, Chowkhamba Sanskrit Series office, Varanasi, Vol - 1, ednreprint- 2019 chp 6 , Shloka 8 page no. 227 5 Dr. Ram Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita, Text with English translation & critical exposition based on chakrapani dutta Ayurveda dipika, Chowkhamba Sanskrit Series office, Varanasi, Vol -4, edn reprint-2014, Chap- 15 shloka- 47 page no. 2 6 Acharya Shri yadyunandan Upadhyay, shri vijyarakshit, madhav nidanam madhukosh vyakhya , Chowkhamba Sanskrit Series office, Varanasi, Vol - 1, ednreprint- 2019 chp 6 , Shloka 5 page no. 223 7 Dr. R am Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita, Text with English translation & critical exposition based on chakrapani dutta Ayurveda dipika Chowkhamba Sanskrit Series office. Varanasi, Vol-2, edn reprint-2013, chap- 4 Shloka no -6 page no - 54 8 Shushruta samhita, part-1 edited by Ambikadata Shastri,Chaukhamba Sanskrit Sansthana, Varanasi,reprinted 2006, Sutrasthana 46/506, pg no. 287. 9 Shushruta samhita, part-1 edited by Ambikadata Shastri,Chaukhamba Sanskrit Sansthana, Varanasi,reprinted 2006, Sutrasthana 46/509-510, pg no. 287. 10 Charaka Samhita edited by Vaidya Yadavaji Trikamji Acharya Chaukhambha Surbharati Prakashana, Varanasi, 2008, Nidanasthana 4/4-5. 11 Charaka Samhita edited by Vaidya Yadavaji Trikamji Acharya Chaukhambha Surbharati Prakashana, Varanasi, 2008, Chikitsasthana 15/45-49. 12 Charaka Samhita edited by Vaidya Yadavaji Trikamji Acharya Chaukhambha Surbharati Prakashana, Varanasi, 2008, Sutrasthana 28/31-32. 13 Dr. Ram Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita, Text with English translation & critical exposition based on chakrapani dutta Ayurveda dipika Chowkhamba Sanskrit Series office. Varanasi, Vol-3, edn reprint- 2014, chap- 6, Shloka no -26, page no - 306 14 Dr. Ram Karan Sharma, Vaidya Bhagwan Dash. Agnivesa’s Charaka Samhita, Chowkhamba Sanskrit Series office. Varanasi, Vol-3, edn reprint 2014, chap 6, Sloka no 14, page no .303 15 Prof K.R srikantha Murthy, Rog viniscaya, madhav nidan, chowkhamba Sanskrit sansthan , varanasi, edn reprint 2011 , chp- 6 Shloka no. 10, page no. 30 ******************************* How to cite this article: Hardik, Apala Sengupta, Chinky. Studies on genesis of Prameha from Amajirna w.s.r. to biochemical parameters. J Ayurveda Integr Med Sci 2024;11:64-76. http://dx.doi.org/10.21760/jaims.9.11.10 Source of Support: Nil, Conflict of Interest: None declared. Copyright © 2024 The Author(s); Published by Maharshi Charaka Ayurveda Organization, Vijayapur (Regd). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc-sa/4.0), which permits unrestricted use, distribution, and perform the work and make derivative works based on it only for non-commercial purposes, provided the original work is properly cited

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Sama, Kapha, Ama, Manda, Vishama, Pippali, Agnimandya, Prameha, Musta, Koshtha, At, H, Sthulaksha, Amajirna, Data collection, Highly significant, Diagnostic approach, Statistical analysis, Group A, Follow-up, Inclusion criteria, Exclusion criteria, Cardinal sign, Sample size, Clinical trial, Treatment Protocol, Marked improvement, Statistically Significant, Study population, Treatment duration, Effect of therapy, Experimental group, Moderate improvement, Randomized study, Interventional study, Paired T test, Significant improvement, Unpaired 't' test, Group A and group B, Subjective Criteria, Objective Criteria, FBS, Simple random sampling, Mild improvement, Subjective parameter, Objective parameter, Pippali churna, Chief complaint, Musta Churna, Overall effect, Prospective study, Kapha dominance, Standard Error of Mean, Alkaline phosphatase, Wilcoxon signed-rank test, Randomized method, Controlled clinical trial, Kara Pada Daha, PPBS, Hypo Functioning, SGOT, SGPT, Serum amylase, Biochemical parameter, Clinical parameter, Serum lipase, SGOT Level, SGPT Level, Study variables, Single blind, Drop-out rate, Group B, HbA 1 c, BT, Meda Dushti, S.D, S.E, Unpaired t test, Tikshana, Baseline parameter, HbA 1 c level.