Clinical trial to evaluate the addon effect of Vimlapana Karma in Dushta...

[Full title: Clinical trial to evaluate the addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer: A Randomised Controlled Trial]

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

ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 16 Clinical trial to evaluate the addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer: A Randomised Controlled Trial Vanishree Tuppad 1 , Shilpa PN 2 1 Post Graduate Scholar, Dept. of PG & Phd Studies in Shalyatantra, Govt. Ayurvedic Medical College Bangalore, Karnataka, India. 2 Professor, Dept. of PG & Phd Studies in Shalyatantra, Govt. Ayurvedic Medical College Bangalore, Karnataka, India. I NTRODUCTION Varicose ulcers are the most prevalent complication of varicose veins, likely to affect many patients during their lifetime. Varicose ulcers, also referred to as venous insufficiency ulcers, venous leg ulcers, or gravitational ulcers, are a severe and debilitating consequence of chronic venous insufficiency. A chronic venous ulcer can be defined as an area of discontinuity of epidermis, persisting for four weeks or more and Address for correspondence: Dr. Vanishree Tuppad Post Graduate Scholar, Dept. of PG & Phd Studies in Shalyatantra, Govt. Ayurvedic Medical College Bangalore, Karnataka, India. E-mail: tuppadvanishree 94@gmail.com Submission Date: 12/11/2024 Accepted Date: 24/12/2024 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.9.12.3 occurring as a result of venous hypertension and calf muscle pump insufficiency [1] Venous leg ulcers (VLUs) are open lesions of the lower limb and represent between 60 to 80% of all leg ulcer [2] It is the commonest painful condition that every patient inflicted with varicose veins and occurs by Ambulatory venous hypertension is the prime cause of venous ulcer formation. The prevalence of chronic venous ulcers in the leg is 70%-80% (2022) and Overall Incidence rate was 0.76% for males and 1.42%in females (2018) [3] In Varicose ulcer various growth factors and inflammatory cells, which get trapped in the fibrin cuff promote severe uncontrolled inflammation in surrounding tissue preventing proper regeneration of wounds. Leukocytes get trapped in capillaries, releasing proteolytic enzymes and reactive oxygen metabolites, which cause endothelial damage. These injured capillaries become increasingly permeable to various macromolecules, accentuating fibrin deposition [4] Occlusion by leukocytes also causes local A B S T R A C T Dushta Vrana , associated with delayed healing and correlated with varicose ulcers, arises from venous insufficiency. According to Sushrut Samhita , Ayurvedic treatments like Vimlapana Karma and Jalaukavacharana are emphasized for their wound-healing and anti-inflammatory properties, while Saptopakrama and Shasti Upakrama address Vrana Shopha and Vrana . This study explores the additive effect of Vimlapana Karma on the standard treatment of Jalaukavacharana for Dushta Vrana . Forty patients with Dushta Vrana were randomly assigned to two groups: Group A received wound dressing and Jalaukavacharana , while Group B received Vimlapana Karma and Jalaukavacharana, both over 21 days. Both Group A ( Jalaukavacharana ) and Group B ( Vimlapana Karma with Jalaukavacharana ) showed statistically significant improvements (p < 0.001) in ulcer size, edges, exudate, surrounding skin color, and granulation tissue formation. Combining Jalaukavacharana with Vimlapana Karma significantly enhanced wound healing and accelerated recovery in Dushta Vrana (varicose ulcers). Key words: Dushta Vrana, Vimlapana Karma, Jalaukavacharana, Saptopakrama, Chronic wounds, Nonhealing ulcer.

[Find the meaning and references behind the names: Long, Deep]

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 17 ischemia thereby increasing tissue hypoxia and reperfusion damage So, it is the responsibility of surgeon that it should be cured within short period with less pain and less cost. Conservative management of varicose ulcer includes compression, stocking, elevation of limb, antibiotics usage and regular dressing of the wound. Surgical treatments like skin grafting, sclerotherapy, laser ablation or surgical correction of superficial venous reflux practice are in use. However, recurrence of venous ulcer about 75% develop within a 3 weeks and on average 60% Healed by 12 weeks. Untreated ulcers have complications like infection, loss of mobility, cellulites, gangrene and eventually lead to amputation of a limb [5] Varicose ulcer is correlated to Dushtavrana having classical features [6] such as Ativivruta (too wide), Atikhatina (too hard), Atiutsanna (extremely elevated), Atyushna (too hot), Pootipuyasrav (Purulent discharge), Dheergha Kalanubandi (long duration). In Sushruta Samhita (17 th chapter of Sutrasthana: Aamapakveshaneeya Adhyaya [7] and 1 st chapter of Chikitsa Sthana : Dwivraniya Chikitsitam Adhyaya), [8] Vimlapana Karma [9] (gentle massage) is recommended for managing Vrana Shotha (wound inflammation) and Vrana (wound). This preliminary treatment relieves Vata-Kapha dosha obstruction, promoting wound healing by increasing local temperature, relaxing vasoconstriction, enhancing oxygenation and nutrient delivery to the wound site, removing accumulated toxins, and accelerating wound healing. To relieve such obstruction, sensitize the cells in and around the wound, and enhance the rate of wound healing, Vimlapana Karma was selected. Vimlapana Karma resolved inflammation around the wound and improved blood circulation, thereby aiding in early wound healing. After, Vimlapana Karma Jalaukaavacharana (leech therapy) was performed. Jalaukavacharanaha [10] has its own benefits viz.- Jalauka (Leech) is anti-phlogistic, i.e. used for relief of local inflammation in tissue and has capability of improving microcirculation. Jalaukavacharana being a bio-purificatory method removes deep seated toxins by letting out blood, clearing Srotasa and pacifying vitiated Do ṣ ha . It is indicated in Pittaja and Raktaja Dosha conditions and act on improving the microcirculation and vasodilatation by decreasing the venous pressure hence improves tissue perfusion and help in wound healing. A IMS AND O BJECTIVES 1 To evaluate the effect of Jalaukavacharana in Dushtavrana w.s.r to Varicose ulcer. 2 To evaluate the combined effect of Vimlapana Karma and Jalaukavacharana in Dushtavrana w.s.r to Varicose ulcer. 3 To compare the combined effect of Vimlapana Karma followed by Jalaukavacharana with Jalaukavacharana in Dushtavrana w.s.r to Varicose ulcer. Hypothesis Null Hypothesis ▪ There is no significant effect of Vimlpana Karma followed by Jalaukavacharan in Dushta Vrana w.s.r. to Varicose ulcer ▪ There is no significant effect of Jalaukavacharan in Dushta Vrana w.s.r. to Varicose ulcer ▪ There is both group Vimlapana Karma followed by Jalaukavacharana and Jalaukavacharana in Dushta Vrana w.s.r. to Varicose ulcer is comparable Alternate Hypothesis ▪ There is significant effect of Vimlpan a Karma followed by Jalaukavacharan a in Dushta Vrana w.s.r. to Varicose ulcer. ▪ There is significant effect of Jalaukavacharana in Dushta Vrana w.s.r. to Varicose ulcer. ▪ There is both group Vimlapana Karma followed by Jalaukavacharana and Jalaukavacharana in Dushta Vrana w.s.r. to Varicose ulcer is not comparable.

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 18 M ETHODOLOGY This study was conducted between September 2023 to August 2024 Source of Data Subjects with clinical features of Dushtavrana fulfilling the inclusion criteria approaching the OPD and IPD of Shalya tantra, Government Ayurveda and Unani Hospital, Bengaluru were selected for the study. The sample collection was initiated after post approval from the institutional ethics committee. Sampling Design The subjects who fulfil the inclusion criteria and complying with the informed consent (IC) were selected using method of simple random sampling. Inclusion Criteria ▪ Selection of patients is done irrespective of religion, occupation, economic and educational status. ▪ Age (20 to 80 year) ▪ Patient presented with classical features of Dushtavrana ▪ Patient presented with clinical features of varicose ulcer. Exclusion Criteria ▪ Patients with conditions like Systemic disorders, HIV, HBsAg, Burn wounds, Osteomyelitis, Gangrene, Diabetic foot ulcer, Bleeding Disorder Study Design Groups Topical Treatment Duration Group A Jalaukavacharana 21 days Group B Vimlpana Karma f/b Jalukavacharana 21 days Procedure Group A: Jalaukavacharana ▪ All required investigations were done. ▪ Under all aseptic precautions. Vranaprakshalana done with Panchavalkala Kashaya. ▪ Jatyadi Taila was applied; the wound was closed with dressing and bandage (1 st to 6 th day). 7 th day Jalaukavacharan procedure was done. Purvakarma ▪ Jalauka was placed in a kidney tray containing Haridra Jala . Once Jalauka get activated it was considered fit for procedure. ▪ Subject made to sit comfortably with extended leg and back rest. Part intended for Jalauka application was cleaned and made rough by Rubbing ( Vigharshana ) with dry Gauze. Pradhan Karma ▪ The Jalauka was brought into contact with the intended site. When the Jalauka was attached firmly to the intended site, it was covered with wet gauze and was moistened at intervals until the end of the procedure. ▪ The Jalauka detached voluntarily; in cases where the Jalauka did not detach by itself, it was removed after 45 minutes. Paschat Karma ▪ Haemostasis was achieved by applying a pressure bandage. ▪ The Jalauka Vamana procedure was carried out. ▪ The patient was advised to come for daily dressing. In case of a reduction in wound size within the time period of 21 days, the patient was advised to stop further treatment. Group B: Treated with Vimlapana Karma followed by Jalaukavacharana Vimlapana Karma followed by Jalaukavacharana Vimlapana Karma Purvakarma ▪ The procedure was performed under aseptic precautions, during which gloves were worn. ▪ Vranaprakshalana was performed using Panchavalkala Kashaya . The area was then wiped clean with gauze.

[Find the meaning and references behind the names: Jensen, Mann, Red, Bright]

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 19 Pradhan Karma ▪ Jatyadi Taila was applied around the edge of the wound. ▪ According to the size of the ulcer, the palm, thumb, or pulp of fingers were used to massage around the ulcer area in a circular fashion, for a duration of 15- 20 minutes. Paschat Karma ▪ After applying Jatyadi Taila, the wound was dressed and bandaged. 7 th day Jalaukavacharana was done ▪ Jalaukavaacharana was performed, followed by Vranaprakshalana with Panchavalkala Kashaya. Jatyadi Taila was applied, and the wound was dressed and bandaged. ▪ The patient received daily dressing instructions. In case of reduction in wound size within the time period of 21 days, then patient was advised to stop further treatment. Duration of Treatment Duration of treatment was 21 days. Subjective and Objective parameters was assessed on before treatment (0 th day), 7 th day, 14 th day, and 21 st day Statistical design Statistical test for within the groups Wilcoxon signed rank test – for all parameters. Statistical test for between the groups Mann Whitney ‘U’ test – for all parameters.The differences in the mean values were considered, the corresponding p value was noted, and the results obtained were interpreted as Highly significant at p<0.001 and p<0.01, significant at p<0.05 Assessment Criteria Assessment of the study was done before treatment, during and after treatment and at follow-up on the basis of assessment parameters as per case proforma Bates-Jensen Criteria for Wound Assessment Gradation of Parameters Size Grade 1 - Length X Width < 4 sq.cm Grade 2 - Length X Width 4 -< 16 sq.cm Grade 3 - Length X Width 16.1 -< 36 sq.cm Grade 4 - Length X Width 36.1 -< 80 sq.cm Grade 5 - Length X Width > 80 sq.cm. Edge Grade 1 - Indistinct, diffuse, none clearly visible. Grade 2 - Distinct, outline clearly visible, attached, even with wound base. Grade 3 - Well defined, not attached to wound base. Grade 4 - Well defined, not attached to base, rolled under, thickened. Grade 5 - Well defined, fibrotic, scarred or hyperkeratosis. Exudate Type Grade 1 - None. Grade 2 - Bloody Grade 3 - Serosanguineous, thin, watery, pale, red /pink. Grade 4 - Serous, thin, watery, clear. Grade 5 - Purulent, thin or thick, opaque, tan/yellow, with or without odor. Skin Colour Surrounding Area Grade 1 - Pink or normal for an ethnic group. Grade 2 - Bright red &/or blanches to touch. Grade 3 - White or grey pallor or hypo pigmented. Grade 4 - Dark red or purple &/or non-bleachable Grade 5 - Black or hyper pigmented. Granulation Tissue Grade 1 - Skin intact or partial thickness wound. Grade 2 - Bright, beefy red; 75% to 100% of wound filled &/or tissue over growth. Grade 3 - Bright, beefy red; 75%to>25%0 f wound. Grade 4 - Pink, &/or dull, dusky red &/or fills<25% of wound. Grade 5 - No granulation tissue present

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 20 O BSERVATION AND R ESULTS Clinically diagnosed 40 subjects of Dushta Vrana w.s.r. to Varicose ulcer were randomly selected and assigned in two groups of 20 subjects each for study. Group-A was treated with Jalaukavacharana followed by daily dressing for a period of 21 days and Group-B was treated with Vimlapana Karama followed by Jalaukavacharana and daily dressing for 21 days. Observation of Patients profile The study found that both groups had a similar distribution in terms of gender (p=1.000), socioeconomic status (p=0.33), occupation (p=0.07), diet (p=0.05), and a family history of Varicose vein or ulcer (p=1.00). There were significant differences in the age distribution (p=0.77), mean ulcer chronicity (p=0.82), Affected limb(p=0.32), and position of ulcer (p=0.28). Results 1. Effect on Size Table 1: Effect of treatment on Size (between the group) Variabl e Group N Mean Rank Sum of Ranks Mann - Whitn ey U P- Value Res ult Size Group A 20 13.60 272.00 62.00 0 0.0000 4 Sig Group B 20 27.40 548.00 Total 40 The study data indicates that, effect of therapy on size of the ulcer before and after the intervention between the group showed significant difference(p<0.001) favouring towards group B (with higher mean change of 27.40). Table 2: Effect of treatment on Size (within the group) Size Me an Medi an SD SE Wilco xon Z P- Value % Effe ct Resu lt Gro up A BT 2.85 3.00 0.8 8 0.2 0 - - - - Da y 7 2.85 3.00 0.8 8 0.2 0 .000 b 1.0000 00 0.00 NS Da y 14 2.70 2.00 0.9 2 0.2 1 - 1.732 c 0.0832 65 5.26 NS Da y 21 2.45 2.00 0.8 3 0.1 8 - 2.530 c 0.0114 12 14.0 4 Sig Gro up B BT 3.05 3.00 0.7 6 0.1 7 - - - - Da y 7 3.00 3.00 0.7 3 0.1 6 - 1.000 b 0.3173 11 1 .64 NS Da y 14 2.35 2.00 0.6 7 0.1 5 - 3.500 b 0.0004 65 22.9 5 Sig Da y 21 1.75 2.00 0.5 5 0.1 2 - 4.130 b 0.0000 36 42.6 2 Sig Effect of therapy on size within the group analysis on size of the ulcer different time interval showed that, group A had shown significant changes on 21 st day of intervention(p=0.01), whereas group B showed significant changes on 14 th (p<0.001) and 21 st(p<0.001) day of intervention. 2. Effect on Edge Table 3: Effect of treatment on Edge (between the group) Varia ble Group N Mean Rank Sum of Ranks Mann- Whitney U P- Value Resu lt Edge Group A 20 13.20 264.00 54.000 0.000 01 Sig Group B 20 27.80 556.00 Total 40 Based on the trial results, group B (with a larger mean change of 27.80) prevailed in the significant difference (p<0.001) between the intervention effect on the ulcer's edge preceding and following the intervention.

[Find the meaning and references behind the names: Med, Ian]

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 21 Table 4: Effect of treatment on Edge (within the group) Edge Me an Me dian S D SE Wilc oxon Z P- Value % Eff ect Res ult Gr ou p A B T 3.3 5 3.00 0. 59 0. 13 - - - - D a y 7 3.3 5 3.00 0. 59 0. 13 .000 b 1.000 000 0.0 0 NS D a y 1 4 2.6 5 3.00 0. 67 0. 15 - 3.74 2 c 0.000 183 20. 90 Sig D a y 2 1 2.4 5 2.50 0. 60 0. 14 - 4.24 3 c 0.000 022 26. 87 Sig Gr ou p B B T 3.6 0 4.00 0. 60 0. 13 - - - - D a y 7 3.2 0 3.00 0. 52 0. 12 - 2.82 8 b 0.004 678 11. 11 Sig D a y 1 4 2.5 0 2.50 0. 51 0. 11 - 3.94 7 b 0.000 079 30. 56 Sig D a y 2 1 1.8 0 2.00 0. 52 0. 12 - 4.03 5 b 0.000 055 50. 00 Sig The edge of the ulcer statistical analysis revealed that group A had significant changes on the 14 th day of the intervention (p<0.01), while group B showed significant changes on the 7 th, 14 th, and 21 st days of the intervention (p<0.001), respectively. 3. Effect on the Exudate Type Table 5: Effect of treatment on Exudate type (between the group) Vari able Group N Mean Rank Sum of Ranks Mann- Whitn ey U P- Valu e Res ult Exu date type Group A 2 0 16.75 335.00 125.00 0 0.01 418 Sig Group B 2 0 24.25 485.00 Total 4 0 The research findings demonstrate that the treatment impact on ulcer exudate type from before to after the intervention differed significantly (p<0.05), preferring group B (whose mean change increased at 24.25). Table 6: Effect of treatment on Exudate type (within the group) Exudate type Me an Med ian SD SE Wilco xon Z P- Value % Eff ect Res ult Gro up A BT 3.5 5 3.00 0. 69 0. 15 - - - - D ay 7 2.9 0 3.00 0. 85 0. 19 - 3.606 c 0.000 311 18. 31 Sig D ay 14 2.3 0 2.00 0. 98 0. 22 - 3.852 c 0.000 117 35. 21 Sig D ay 21 1.7 5 1.00 0. 91 0. 20 - 4.035 c 0.000 055 50. 70 Sig Gro up B BT 3.2 5 3.00 0. 44 0. 10 - - - - D ay 7 2.4 0 2.00 0. 50 0. 11 - 4.123 b 0.000 037 26. 15 Sig

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 22 D ay 14 1.3 5 1.00 0. 49 0. 11 - 4.177 b 0.000 030 58. 46 Sig D ay 21 1.0 0 1.00 0. 00 0. 00 - 4.134 b 0.000 036 69. 23 Sig According to the data analysis of the ulcer exudate, group B revealed substantial changes on day 7 th of the intervention (p<0.001), whereas group A exhibited significant changes on day 7 th (p<0.001). 4. Effect on the Skin Colour Surrounding Area Table 7: Effect of treatment on Skin colour surrounding area (between the group) Varia ble Grou p N Mean Rank Sum of Ranks Mann- Whitney U P- Value Resul t Skin colour surro undin g area Grou p A 2 0 17.55 351.00 141.000 0.022 18 Sig Grou p B 2 0 23.45 469.00 Total 4 0 The effect of the intervention on the skin colour surrounding the ulcer area before and after treatment was shown to differ significantly (p<0.05) between Group B mean rank of 23.45 and the trial results. This indicates that Group B skin colour changes in the healing of the surrounding area improved more noticeably than Group A. Table 8: Effect of treatment on Skin colour surrounding area (within the group) Skin colour surroundi ng area Mea n Medi an SD SE Wilco xon Z P- Value % Effe ct Resu lt Gro up A BT 4.65 5.00 0.7 5 0.1 7 - - - - Da y 7 4.60 5.00 0.8 2 0.1 8 - 1.000 c 0.3173 11 1.08 NS Da y 14 4.60 5.00 0.8 2 0.1 8 - 1.000 c 0.3173 11 1.08 NS Da y 21 4.55 5.00 0.9 4 0.2 1 - 1.000 c 0.3173 11 2.15 NS Gro up B BT 4.55 5.00 0.8 9 0.2 0 - - - - Da y 7 4.30 5.00 1.0 3 0.2 3 - 1.890 b 0.0587 82 5.49 NS Da y 14 4.15 5.00 1.2 7 0.2 8 - 2.271 b 0.0231 41 8.79 Sig Da y 21 3.95 5.00 1.5 7 0.3 5 - 2.401 b 0.0163 51 13.1 9 Sig The group analysis pertaining to the changes of skin colour surrounding the ulcer at different time intervals revealed that group B exhibited substantial changes on the 14 th (p<0.05) and 21 st (p<0.05) day of intervention, while group A showed no significant changes on the 21 st day of intervention (p>0.05). 5. Effect on Granulation Tissue Table 9: Effect of treatment on Granulation tissue (between the group) Varia ble Gro up N Mean Rank Sum of Ranks Mann- Whitney U P- Val ue Re sul t Granu lation tissue Gro up A 2 0 14.43 288.50 78.500 0.0 000 9 Sig Gro up B 2 0 26.58 531.50 Tot al 4 0 The study findings indicate that group B had a greater mean change of 26.58 and was superior in terms of a significant difference (p<0.001) between the intervention effect on the granulation tissue of the ulcer before and after the intervention.

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

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 23 Table 10: Effect of treatment on Granulation tissue (within the group) Granulat ion tissue Me an Med ian SD SE Wilco xon Z P- Value % Effe ct Res ult Gro up A BT 3.6 5 4.00 0. 49 0. 11 - - - - Da y 7 3.6 0 4.00 0. 50 0. 11 - 1.000 c 0.317 311 1.3 7 NS Da y 14 2.9 5 3.00 0. 51 0. 11 - 3.742 c 0.000 183 19. 18 Sig Da y 21 2.6 0 3.00 0. 60 0. 13 - 4.379 c 0.000 012 28. 77 Sig Gro up B BT 3.6 5 4.00 0. 49 0. 11 - - - - Da y 7 3.4 0 3.00 0. 50 0. 11 - 2.236 b 0.025 347 6.8 5 Sig Da y 14 2.4 5 2.00 0. 51 0. 11 - 4.179 b 0.000 029 32. 88 Sig Da y 21 1.8 5 2.00 0. 49 0. 11 - 3.999 b 0.000 064 49. 32 Sig In the group analysis, substantial changes were observed in the granulation tissue of the ulcer on day 14 (p=0.001), while group B showed significant changes on day 7 (p<0.05), day 14, and day 21 (p<0.001) of the intervention. Table 11: Total Percentage of Improvement observed in Group A and Group B Parameter % Effect Group A Group B Size 14.04 42.62 Edge 26.87 50.00 Exudate type 50.70 69.23 Skin colour surrounding area 2.15 13.19 Granulation tissue 28.77 49.32 Average % Effect 24.50 44.87 Group B outperformed Group A in ulcer healing, with a 42.62% reduction in ulcer size compared to 14.04%. Group B also showed greater improvements in ulcer edge (50% vs 26.87%), exudate type (69.23% vs 50.70%), skin color (13.19% vs 2.15%), and granulation tissue (49.32% vs 28.77%). Overall, Group B had a 44.87% improvement, while Group A had 24.50%, indicating more effective treatment in Group B. Graph 1: Overall Effect of treatment on the Group A and Group B DISCUSSION Discussion of demographic data This study found that varicose veins and ulcers commonly begin after age 20, with a peak in the fourth decade. Among participants, 97.05% were male, though historical data suggests women may also be predisposed due to pregnancy and hormones. Most participants were middle-class (50%) or lower-middleclass (45%), with 75% engaged in occupations involving prolonged standing or sedentary work, contributing to poor circulation and delayed healing. Mixed diets were prevalent (80%), with vegetarian diets potentially aiding wound healing. Family history was absent in 85% 0.00 10.00 20.00 30.00 40.00 50.00 60.00 70.00 14.04 26.87 50.70 2.15 28.77 24.50 42.62 50.00 69.23 13.19 49.32 44.87 % Effect % Effect Group A % Effect Group B

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 24 of cases, highlighting lifestyle as a major factor. The right limb was most affected (45%), followed by the left (30%) and bilateral cases (25%), with chronicity ranging from less than a year (42.07%) to over five years (7.05%). Ulcers were common at the medial malleolus (50%), and both solitary and multiple ulcers were equally distributed, reflecting the need for timely, personalized management to prevent complications. Discussion on Results Effect on Size: According to the study, Group B ( Jalaukavacharana and Vimlapana Karma ) significantly performed Group A ( Jalaukavacharana ) with a 42.62% reduction in ulcer size. A comparison for the groups showed p<0.05, signifying more effective results, while Group B showed a highly significant effect (p<0.001). Although it affects slower, Jalaukavacharana alone minimises toxins and inflammation. By minimising vasoconstriction, enhancing neovascularisation, and accelerating up recovery, the combination treatment in Group B, on the opposite hand, enhanced healing and was more successful in decreasing ulcer size. Effect on Edge: In the study, Group A (Jalaukavacharana ) showed a 26.87% improvement in wound edge healing, while Group B ( Vimlapana Karma and Jalaukavacharana) showed 50% improvement. Both therapies promote wound contraction through fibroblasts and collagen. Jalaukavacharana enhances tissue penetration and toxin removal. In Group B, the combination therapy boosts circulation and reduces inflammation, while Jalaukavacharana accelerates microcirculation, promoting faster wound edge healing in chronic varicose ulcers. Effect on Edge: Significant improvements in exudate type were shown by Group A ( Jalaukavacharana) and Group B ( Vimlapana Karma and Jalaukavacharana ), with Group A demonstrating a 50.70% improvement and Group B a 69.23% improvement. While Vimlapana Karma cures the underlying cause by purifying blood and minimising inflammation, Jalaukavacharana decreases exudates by harmonising doshas and improving venous function. The combination accelerates wound healing effectively decreases exudate. Effect on Skin colour of Surrounding area: Skin colour did not change significantly in Group A ( Jalaukavacharana ) (2.15%, p > 0.05), but it did significantly improve in Group B (Vimlapana Karma and Jalaukavacharana ) (13.19%, p < 0.05). While Group B's healing might be the result of Vimlapana Karma's improvement of circulation, reepithelialization, and blood purification, which encouraged healing and decreased inflammation, Group A's lack of change may be explained by the gradual effect of leech therapy. Effect on Granulation tissues: Granulation tissue in Group A ( Jalaukavacharana) and Group B ( Vimlapana Karma and Jalaukavacharana) improved significantly; Group A's improvement was 28.77%, while Group B's was 49.32%. By increasing the effectiveness of its components, Jalaukavacharana improves granulation and lowers inflammation in Group A. Vimlapana Karma from Group B enhances tissue healing and circulation by stimulating the growth of healthy granulation tissue. Probable mode of action of Vimlapana Karma : Vimlapana Karma in Dushta Vrana facilitates wound healing by relieving local vasoconstriction, improving circulation at the wound site, and enhancing oxygen supply. This is where mechanotransduction — a key process — comes into play. Mechanotransduction is the conversion of a mechanical stimulus into a biochemical response within cells. In the context of wound healing, mechanical forces from actions like massage stimulate cells, prompting signalling pathways that enhance tissue repair and regeneration 11 . Studies show that massage acts as an immune modulator, influencing neutrophils' apoptotic signalling, reducing the release of proinflammatory cytokines 12 , and promoting tissue repair. Additionally, the mechanical pressure during massage increases local temperature, improving blood flow by relieving vasoconstriction and carrying essential nutrients, oxygen, and insulin to the wound site. This improved circulation aids in alleviating the anoxic condition of the wound. Mechanotransduction also promotes the release of beta-endorphins, which

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 25 provide pain relief 13 . With improved blood flow and nutrient delivery, epithelial cell regeneration is accelerated, leading to faster healing of the extracellular matrix (ECM) — a critical component in dermal repair, particularly for varicose ulcers. CONCLUSION The study found that most participants were male, aged 41-50, predominantly, followed a mixed diet, and had varicose ulcers with a chronicity of 1 to 5 years. Group B ( Vimlapana Karma followed by Jalaukavacharana ) was more effective in managing varicose ulcers, showing significant improvements in ulcer size, edge, exudate type, skin color, and granulation tissue compared to Group A ( Jalaukavacharana ). Group B consistently outperformed Group A, with an average improvement of 44.87% in Group B versus 24.50% in Group A. Statistically significant differences were observed at all time points (BT, Day 7, Day 14, and Day 21), with Group B demonstrating superior results. No adverse effects were reported in either group. The study supports the hypothesis that Vimlapana Karma provides a significant added benefit to Jalaukavacharana. Vimlapana Karma is a cost-effective, feasible, and simple procedure with minimal equipment requirements and no complications, confirming its significant role in enhancing the treatment of varicose ulcers. Before and After treatment in Group-A Before treatment During treatment Vimlapana Karma During Jalaukavacharana After treatment

[Find the meaning and references behind the names: Shri, Sri, Shree, Laura, Francis, Wang, Saini, John, Love, Wong, Raton, Mary, Prakashan]

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 26 Before and After treatment in Group-B Before treatment 7 th day Jalaukavacharana After treatment REFERENCES 1 WHO Library Cataloguing in Publication Data. Wound and lymphoedema management. 2010. Edited by John M. Macdonald, Mary Jo Geyer, Laura L. Bolton. New Jersey: University of Medicine and Dentistry of New Jersey, Department of Surgery (Bioengineering). 2 Probst S, Weller CD, Bobbink P, Saini C, Pugliese M, Skinner MB, Gethin G. Prevalence and incidence of venous leg ulcers - a protocol for a systematic review. Syst Rev. 2021 May 12;10(1):148. doi:10.1186/s 13643- 021-01697-3. PMID:33980324; PMCID:PMC 8117489. 3 Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg ulcer: Incidence and prevalence in the elderly. J Am Acad Dermatol. 2002;46(3):381-6. doi: 10.1067/mjd.2002.121739. 4 O'Connell PR, McCaskie AW, Sayers RD, editors. Bailey & Love’s Short Practice of Surgery. 28 th ed. Boca Raton: CRC Press, Taylor & Francis Group; 2023. 5 Bland KI, Sarr MG, Wong J. Principles of Surgery. 10 th ed. New York: McGraw-Hill Education; 2012. p. 264. 6 Acharya S, editor. Sushruta Samhita with Nibandha Sangraha commentary of Sri Dalhanacharya. 6 th ed. Varanasi: Chaukambha Surabharati Prakashan; 2010. Sutra Sthana, Chapter-22, Verse-8, pp. 824, p. 109. 7 Acharya S, editor. Sushruta Samhita with commentary of Dalhana. Reprint. Varanasi: Chaukambha Publications; 2006. Chapter-17. 8 Acharya S, editor. Sushruta Samhita with Nibandha Sangraha commentary of Sri Dalhanacharya. Reprint. Varanasi: Chaukambha Surabharati Prakashan; 2010. Chikitsa Sthana, Chapter-1. 9 Acharya S, editor. Sushruta Samhita with Nibandha Sangraha commentary of Sri Dalhanacharya. Reprint. Varanasi: Chaukambha Surabharati Prakashan; 2010. Chikitsa Sthana, Chapter-1, Verse-22-23, pp. 824, p. 395. 10 Acharya S, Acharya N, editors. Sushruta Samhita with Nibandhasaarasangraha Commentary of Shree Dhalhana Acharya and Nyaaya Candrikaakhya Panjika Vyaakhyaa of Shree Gayaadas Acharya. 6 th ed. Varanasi: Chaukambha Sanskrit Sansthan; 2017. Sutra Sthana, Chapter-13, Shloka-24, p. 58. 11 Wang N, Tytell JD, Ingber DE. Mechanotransduction at a distance: mechanically coupling the extracellular matrix with the nucleus. Nat Rev Mol Cell Biol. 2009;10(1):75- 82. 12 Waters-Banker C, Tuttle N, Hammer W, Pfeiffer J. Investigating the Mechanisms of Massage Efficacy: The

[Find the meaning and references behind the names: Shin, Nil]

Vanishree Tuppad et al. Addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer ISSN: 2456-3110 ORIGINAL ARTICLE December 2024 Journal of Ayurveda and Integrated Medical Sciences | December 2024 | Vol. 9 | Issue 12 27 Role of Mechanical Immunomodulation. J Bodyw Mov Ther. 2014;18(3):456-65. 13 Shin TM, Bordeaux JS. The role of massage in scar management: A literature review. Dermatol Surg. 2012;38(3):414-23. ******************************* How to cite this article: Vanishree Tuppad, Shilpa PN. Clinical trial to evaluate the addon effect of Vimlapana Karma in Dushta Vrana w.s.r. to Varicose Ulcer: A Randomised Controlled Trial. J Ayurveda Integr Med Sci 2024;12:16-27. http://dx.doi.org/10.21760/jaims.9.12.3 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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Dushtavrana, Vrana, Atyushna, Jalaukavacharana, Gentle massage, Surgical treatment, Wound dressing, Ayurvedic treatment, Skin-color, Wound healing, Statistical analysis, Group A, Granulation tissue, Significant change, Inclusion criteria, Exclusion criteria, Clinical trial, Assessment criteria, Statistical Significance, Leech therapy, Ayurvedic Medical College, Anti-inflammatory properties, Jatyadi taila, P Value, Sushrut Samhita, Blood purification, Study design, Extracellular matrix, Endothelial damage, Wound healing properties, Institutional ethics committee, Subjective parameter, Objective parameter, Assessment parameter, Conservative management, Skin grafting, Chronic venous insufficiency, Varicose ulcer, Microcirculation, Sclerotherapy, Vasoconstriction, Nutrient delivery, Statistical design, Vata Kapha Dosha, Sample collection, Prolonged standing, Wilcoxon signed-rank test, Venous Insufficiency, Compression stocking, Venous hypertension, Panchavalkala Kashaya, Chronic venous ulcer, Tissue perfusion, Skin Colour, Local temperature, Mixed diet, Vrana Shopha, Venous pressure, Local Inflammation, Nonhealing ulcer, Gangrene, Laser ablation, Wound assessment, Proinflammatory cytokine, Surgical correction, Proteolytic Enzyme, Daily dressing, Venous leg ulcer, Randomised controlled trial, Antibiotics Usage, Tissue Hypoxia, Oxygenation, Ulcer size, Early wound healing, Reactive oxygen metabolite, Leukocytes, Inflammatory cell, Mann-Whitney U-test, Mean rank, Group B, Beta-endorphin.