Clinical Study To Evaluate The Efficacy Of Punarnavadi-Kanamula Yoga...

[Full title: Clinical Study To Evaluate The Efficacy Of Punarnavadi-Kanamula Yoga (Hypothetical) In Hypothyroidism]

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[Find the meaning and references behind the names: Bala, Pir, Sharma, Peer, Fast, Kaya]

P a g e | 41 Research Article. ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION International Research Journal of Ayurveda & Yoga An International Peer Reviewed Journal for Ayurveda & Yoga VOLUME 4 ISSUE 10 1- P.G Scholar, P.G. Department Of Kaya Chikitsa, M.M.M. Govt. Ayurveda College Udaipur 2- Associate. Prof. P.G. Department Of Kaya Chikitsa, M.M.M. Govt. Ayurveda College Udaipur Corresponding Author :- Hrishabh Datt Sharma , P.G Scholar, P.G. Department Of Kaya Chikitsa, M.M.M. Govt. Ayurveda College Udaipur, Email,Idhrishabh 030894@gmail.com Article received on 15 th Sept. 2021 Article Accepted 24 Oct. 2021 Article published 31 st Oct 2021 ABSTRACT: - Today’s era is all about psycho-somatic diseases. These intimate affections of mind & fast moving society have disturbed the psychosomatic structure of human beings which has led to various disorders e.g. hypertension, diabetes, ulcerative colitis and various endocrine related abnormalities. Modern era is influencing both body & mind status of the individual. Pathogenesis of hypothyroidism according to the principles of Ayurveda, we find ourselves around the fact that it is basically related to Agni. Dhatwagni is effected adversely due to influence of malfunctioning Jhataragni formed in the pathology of disease hypothyroidism. Hypothyroidism is a metabolic disorder in its net result, there is nothing wrong in comparing with the “ Agnimandhya” principle of Ayurveda. Key Words : Ayurveda, Hypothyroidism, Agnimandhya, Thyroid disorders. This work is licensed under a creative attribution -Non-commercial-No derivatives 4.0 International License commons How to cite this article: Sharma H, Sharma I “Clinical Study To Evaluate The Efficacy Of Punarnavadi-Kanamula Yoga (Hypothetical) In Hypothyroidism” ; IRJAY. [Online] 2021;4(10): 41-49. Available from : http://irjay.com ; DOI:-https://doi.org/10.47223/IRJAY.2021.41005 Clinical Study To Evaluate The Efficacy Of Punarnavadi-Kanamula Yoga (Hypothetical) In Hypothyroidism Hrishabh Datt Sharma, 1 Indumati Sharma 2

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[Find the meaning and references behind the names: Low, Rasa, Pandu]

P a g e | 42 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION INTRODUCTION In the changing and busy life schedule of 21 st century, Hypothyroidism is considered one of the most common disease. It is caused due to the low thyroid hormone level in the blood. Here the thyroid gland fails to produce enough level of thyroid hormone to undertake the metabolic activities of the body. Thyroid gland produce hormone namely Thyroxine (T 4) and Triiodothyronine (T 3) are involved in all the metabolic procedure of the body and regulates all the function of most of the organs. In the normal situation, the thyroid gland releases 100 - 125 nmol of thyroxine (T 4) daily and only little amounts of tri-iodothyronine (T 3). The halflife of T 4 is approximately 7-10 days. T 4 is a prohormone and T 3 is active form of thyroid hormone. T 4 is converted to T 3 by 5’- deiodination in the peripheral tissues. In the Early stage of disease compensatory mechanisms maintain T 3 levels. Pituitary gland increases the tsh level when production of T 4 decreases. Thyroid stimulating hormone stimulates hypertrophy and hyperplasia of the thyroid gland. It also stimulates de-iodination process and this causes the thyroid to release more T 3. Metabolically active cells of the body require thyroid hormone and effect of hormone deficiency vary. [1],[2],[3] In the Ayurvedic texts, hypothyroidism is not mentioned as a disease directly, but its symptoms can be found similar to many diseases mentioned in Ayurveda like Kapha Sotha , Kapha Galaganda etc. Hypothyroidism shows more similarity with the Kaphaja Sotha in its sign and symptoms which is mainly mentioned by Charak . Since Hypothyroidism is a metabolic disorder in its net result, it is adequate to compare it with the “ Agnimandya ” principle of Ayurveda [4] . Agnimandya is considered as a major cause for every disease in Ayurveda . It is mentioned “ Roga sarvapi mandagno ” highlighting the importance of Agni in the Ayurvedic texts. Agnimandya is found at the level of Jatharagni, Bhutagni and Dhatwagni which can be correlated to hypothyroidism from called to systemic levels in modern terminologies. Hypothyroidism is considered to be Tridoshaja according to Ayurvedic view. Major features like weight gain, hoarseness of voice, depression, cold intolerance point out to its Kaphaja predominance along with its Rasa Dhatu involvement which is reflected in its symptoms like Aruchi, Tandra, Pandu, Agnimandya, Srotorodha etc [5],[6],[7] AIMS AND OBJECTIVES 1 To study etiopathogenesis of hypothyroidism and to explore the clinical consequences in the light of Ayurvedic principles. 2 To assess the role of Punarnavadi-Kanamula Yoga in the management of hypothyroidism. 3 To find out an effective and safe remedy for hypothyroidism. MATERIALS AND METHODS Source of data A. Literary source - Basic information’s on the disease regarding its etiology, pathophysiology, clinical symptoms, prognosis and treatment principles are included in the literary review from the perspective of both Ayurvedic and modern view. B. Patient source - The study included 30 clinically diagnosed hypothyroidism patients who were seen in the OPD and IPD of the Govt. Ayurveda Hospital, Udaipur, which is affiliated with M.M.M. Rajasthan Ayurveda College, Udaipur,

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

P a g e | 43 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION regardless of their religion, age, sex, , occupation, or other factors. C. Informed Consent - The participants of the clinical trial was given full clarification regarding the structure of study and signed consent was obtained before their involvement in the study. D. Selection Criteria – 1. Unexpected weight gain, constipation, hoarseness of speech cold aversion, exhaustion, oedema and depression are among the symptoms reported by participants. 2. Age range: 20 to 60 years old. 3. TSH levels greater than 5 mIU/L were detected in the subjects. E. Exclusion Criteria- 1. Thyroid disease is being monitored, and there is a history of pituitary or adrenal disease. 2. Thyroid abnormality in pregnancy will be excluded. 3. People who were born with hypothyroidism. 4. People who have been diagnosed with a thyroid tumour. 5. Hypothyroidism as a result of surgery. F. Criteria For Withdrawal - 1. If any medical illness or serious adverse effects arise during the trial, they must be treated immediately. 2. The subject expresses a desire to withdraw from the clinical trial. G. Laboratory Investigations: Thyroid Function Test SerumT 3, SerumT 4 , Serum TSH (Thyroid Stimulating Hormone) H. Study Design - Single study Randomized Interventional type Efficacy study Drug And Posology: Drug Punarnavadi - Kanamula Yoga Dose 3 gm churna twice a day Duration 2 month Anupana Luke warm water Contents of drug: [8],[9],[10],[11],[12] S.No. Sanskrit name Botanical name Part used Quantity 1. Punarnava Boerhavia diffusa Whole plant 1 part 2. Shunthi Zingiber officinalis Rhizome 1 part 3. Nishoth Operculina terpethum Root bark 1 part 4. Guduchi Tinospora cordifolia Kand 1 part 5 Amaltas Cassia fistula Phal majja 1 part 6. Haritaki Termenelia chebula Fruit 1 part 7. Devdaru Cedrusdeodara Kand Sar 1 part 8. Pippali Mool Piper longum Root 1 part

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P a g e | 44 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION Follow Up Study: • The clinical trial lasted for 60 days. • Every 15 days, all of the trial's patients were reevaluated for 2 months. ASSESSMENT CRITERIA: The signs and symptoms of hypothyroidism were added to a special proforma, and a standardized scoring system for the signs and symptoms was used by Ayurvedic and Modern guidelines for evaluating the results. 1. Subjective parameters 2. Objective parameters 1. SUBJECTIVE PARAMETERS: To subjectively measure the effect of therapy, all signs and symptoms will be rated according to their severity Parameters Scores 1. Tiredness No tiredness 0 Mild tiredness after exertion 1 Tiredness without exertion 2 Tiredness increases with exertion and routine work 3 Unable to do routine work 4 2. Weakness No weakness 0 Mild weakness but not enough to hamper routine work 1 Can do routine work with effort 2 Requires help to do routine work 3 Unable to do routine work 4 3. Constipation Normal bowel habit 0 Passes stools daily but with slight difficulty 1 Passes hard stools on alternate days 2 Patients need some laxative to pass stool 3 Unable to pass stool even after use of laxative 4 4. Dyspnoea No troubled by shortness of breath on level or uphill 0 Troubled by shortness of breath on level or uphill 1 Walks slower than person of same age 2 Stops after walking 100 yds. Or after few minutes on level ground 3 Too breathless to leave the house or breathless on dressing or undressing 4 5. Hoarseness of Normal voice 0 Patient feels that his /her voice is changing 1

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

P a g e | 45 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION voice Hoarseness of voice 2 Changes in voice pronounced 3 Slurred speech 4 6. Cold intolerance Absent 0 Cold intolerance especially with environmental changes 1 Cold intolerance present in spite of clothing, avoids cold climate 2 Disability present even on normal room temperature 3 Susceptible to even mint temperature fluctuations. 4 7. Menstrual abnormalities Normal menstrual cycle 0 Oligomenorrhea present from 35 day 1 Oligomenorrhea present from 35-45 day 2 Oligomenorrhea present from 45-55 day 3 Oligomenorrhea present above 55 day 4 8. Dry coarse skin Normal skin 0 Mildly dry skin 1 Dryness reduced by application of some lubricant cream 2 Dryness persist even after application of lubricant cream 3 Complete loss of elasticity with scaling and dryness of skin 4 9. Swelling all over body Absent 0 Mild swelling over the body present (Pat.feel heavy body) 1 Moderate swelling all over the body present with periorbital puffiness 2 Severe swelling all over the body with periorbital puffiness 3 Agonizing swelling all over body with puffy face 4 10. Hair loss No 0 Mild 1 Moderate 2 Severe 3 Agonizing 4

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P a g e | 46 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION RESULTS The data obtained in clinical study is subjected to statistical tests and analyzed in three parts as: 1 Subjective Criteria 2 Objective Criteria 3 Overall effect of therapy 1. SUBJECTIVE CRITERIA A) In this clinical study, the percentage of improvement in each parameter of each scale is calculated. B) The subjective parameters are analyzed after evaluating the difference in the B.T. & A.T using Wilcoxon signed-rank test. Variables Mean B.T. Mean A.T Mean Diff. % ‘W’ ‘N’ ‘P’ TIREDNESS 2.633 0.7667 1.867 70.88608 435.00 29 < 0.0001 WEAKNESS 2.233 0.6000 1.633 73.13433 399.00 28 < 0.0001 CONSTIPATION 2.516 0.5161 2.000 79.48718 253.00 22 < 0.0001 DYSPNOEA 1.700 0.6000 1.100 64.70 253.00 22 < 0.0001 HOARSENESS OF VOICE 0.6667 0.3000 0.3667 55 66.000 11 <0.0010 COLD INTOLERANCE 1.167 0.5667 0.6000 51.42857 105.00 14 0.0001 MENSTRUAL ABNORMALITIES 0.6207 0.2759 0.3448 55 28.000 7 0.0156 DRY COARSE SKIN 3.484 1.677 1.806 51.85 253.00 22 < 0.0001 SWELLING ALL OVER BODY 1.633 0.7586 0.9310 55.10204 190.00 19 < 0.0001 OBJECTIVE CRITERIA Paired ‘t’ test was applied to the following objective parameters. Ser. TSH Ser. T 3 Ser. T 4 Investigation Mean Mean D.F. % Change S.D. S.E. ‘t’value P value BT AT T 3 0.9007 0.878 0.0224 2.49 0.2388 0.04359 0.5154 0.6102 T 4 6.192 6.505 -0.313 -5.0551 0.826 0.1509 2.074 0.0471 TSH 10.939 9.793 1.145 10.4705 1.326 0.2422 4.730 0.0001

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

P a g e | 47 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION OVERALL EFFECT OF THERAPY: Parameters No. of patients Overall relief Complete improvement 00 00 Marked improvement 04 13.33 % Moderate improvement 24 80 % Mild Improvement 02 6.66 % No Improvement 00 00 It was observed that there was a moderate improvement in 24 (80%) patients, marked improvement in 4 (13.33%) patients and mild improvement in 2 (6.66%) patients out of the study conducted on 30 patients. DISCUSSION TIREDNESS - Tiredness was reduced in 70.88% of the patients and it was statistically considered extremely significant (p<0.05). Due to Rasa Dhatu Dhusti prevailing in hypothyroidism tiredness felt as a major symptom. This formulation probably act at the Jathragni level and relieve the symptom curing the Ras dhatu Dhusti . WEAKNESS – There was a reduction of weakness in 73.13%. Weakness was due to non nourishment of Dhatu due to Agni vitiation which is acted upon by this formulation which was statistically significant (p < 0.05). CONSTIPATION - Constipation was reduced in 79.48%. It was caused by Apan Vayu Dhusti due to Avaran of Kapha by its Manda Guna . So constipation is relieved by Deepan, Rechana, Shrotoshodhaka and Pachana properties of drugs containing in the drug. It is considered extremely significant. DYSPNOEA - In 64.70% of the patients, dyspnea was relieved, which was caused by Vata kapha dhusti . By the Vatakaphaghna property of the formulation it reduces dyspnea which is considered statistically significant (p< 0.05). HOARSENESS OF VOICE - Kapaha dhusti is considered as the cause for hoarseness of the voice. By kaphaghna property the formulation reduces the hoarseness of voice in 55% patient which was considered statistically significant (P<0.05). COLD INTOLERANCE - In 51.42 % of people there was a reduction in Cold intolerance. This was statistically significant (P<0.05). MENSTRUAL ABNORMALITIES - The abnormality of Ras dhatu caused by the agni dhusti also results in the abnormality of the Updhatu Aartva . By the Deepan, pachana action of formulation these abnormalities are cured in 55% of the patient. DRY COARSE SKIN - Dry skin is caused by Vata dhusti due to the Avarana by Kapha . The formulation by its Vatakaphagna property reduces the symptoms in 51.85 patient which is considered extremely significant (P<0.05). SWELLING ALL OVER BODY - Swelling is due to Kapha Dhusti which is counter acted by Kaphaghna property of formulation which

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[Find the meaning and references behind the names: Motilal, Long, Ama, Medo, Nil]

P a g e | 48 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION reduces the symptom in 55.01% of the patients which is considered statically significant (P<0.05). HAIR LOS S – Due to the Agnimandya there is reduction in Asthi Dhatu there by malnourishment of its Updhatu hair which resulting in excessive hair loss. The formulation by correcting the Agni restores its normalcy, reducing the symptoms in 46.77% which is considered statically significant (P<0.05). CONCLUSION From the clinical trial conducted on hypothyroid patients using Punarnavadi - Kanamula Yoga , the following conclusions are drawn: Nidan Parivarjana is the first and important line of treatment in any disease. In case of hypothyroidism irregular food pattern, excessive sleep, mental stress, lack of physical exercise plays the role of Nidana. In hypothyroidism the Samprapti leads to vitiation of Rasa and Medo dhatu finally resulting in Annavaha, Rasavaha and Medovaha Srotodusti. ❖ As hypothyroidism involves of chronic Agni Dusti and Ama formation, Pachana is to be done for a long duration in order to attain complete cure along with Deepana and Shrotoshodhanam . ❖ In the management of hypothyroidism Dosha samya is to be attained by making use of Kapha Vata shaman property of drugs. ❖ Due to chronic Rasavaha Shrotodusti involved in hypothyroidism, human body lacks the energy and enthusiasm to function. As Rasayana drugs are found more useful in its management. ❖ Efficacy of Punarnavadi - Kanamula Yoga in the management of Hypothyroidism was about 61.55% in subjective parameters. ❖ After the end of the study, it was found that there was a significant reduction in the subjective parameters and non significant change in objective parameters. Acknowledgment: Nil. Financial Support: Nil. Conflict of Interest: Nil REFERENCE 1 Guyton’s and Hall Textbook of Medical Physiology 11 th Edition Pg No. 931 2 Harshmohan, Textbook of Pathology 6 th edition page 804 3 Munjal Y.P API Textbook Of Medicine (Vol-2) 9 th Edition Page 420 4 Sastri S, Charaka Samhita edited Sutra Sthana 12/14 Chaukhamba Surbharati Prakashana ,Varanasi 2014: pg.no.80 5 Sastri S, Charaka Samhita edited Chikitsa Sthana 15/3-4 Chaukhamba Surbharati Prakashana ,Varanasi 2014.pp.90 6 Sastri S, Charaka Samhita edited Sutra Sthana 12/11 Chaukhamba Surbharati Prakashana ,Varanasi 2014.pp 80 7 Shastri H, Dehadhatvagnivigyanam, Motilal Bnarsidas, Delhi,Varansi, Patana, Edition 1977 page 2 8 Ayurvedic pharmacopia of india, published by ministry of health & family welfare, Edition 1, year of publication 2003, volume 1 9 Aggarwal, M. & Kaul, B.L. (1992), The radioprotective effects of piperine in plants, Indian Drugs, Vol. 29 (10)

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P a g e | 49 Research Article . ISSN NO. 2581-785 X IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION 10 Sharma P.V, Dravyaguna vijnana, Basic concepts, volume II, Varanasi, chukhambha Bharati Academy, Revised Edition 2011 11 Shastry J.N Text book of Dravya guna vignana.vol-2 Published by Chaukhamba Sanskrit bhavan,Varanasi-221001-india 11 th edition 2010 12. Ayurvedic pharmacopia of india, published by ministry of health & family welfare, Edition 1, year of publication 2003, volume I,II,III,IV

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