Journal of Ayurveda and Integrated Medical Sciences

Introduction

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 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 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 3weeks 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]

Hypothesis
Null Hypothesis

• There is no significant effect of Vimlpana Karma followed by Jalaukavacharan in Dushta Vranas.r. to Varicose ulcer.
• There is no significant effect of Jalaukavacharan in Dushta Vranas.r. to Varicose ulcer.
• There is both group Vimlapana Karma followed by Jalaukavacharana and Jalaukavacharana in Dushta Vranas.r. to Varicose ulcer is comparable.

Alternate Hypothesis

• There is significant effect of Vimlpana Karma followed by Jalaukavacharana in Dushta Vranas.r. to Varicose ulcer.
• There is significant effect of Jalaukavacharana in Dushta Vranas.r. to Varicose ulcer.
• There is both group Vimlapana Karma followed by Jalaukavacharana and Jalaukavacharana in Dushta Vranas.r. to Varicose ulcer is not comparable.

Methodology

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 80year)
• Patient presented with classical features of Dushtavrana
• Patient presented with clinical features of varicose ulcer.

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.

Pradhan Karma

• Jatyadi Taila was applied around edge of 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.

7th 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 21days. 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 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 study was done before treatment, during & after treatment & at follow-up on basis of assessment parameters as per case proforma

Bates-Jensen Criteria for Wound Assessment

Gradation of Parameters

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)

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)

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 21st(p<0.001) day of intervention.

Table 6: Effect of treatment on Exudate type (within the group)

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)

Table 8: Effect of treatment on Skin colour surrounding area (within the group)

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.

Top of FormGroup 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 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 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-middle-class (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% of cases, highlighting lifestyle as a major factor. The right limb was most affected (45%), followed by the left (30%) and bilateral cases (25%),

While Group B's healing might be result of Vimlapana Karma's improvement of circulation, re-epithelialization, and blood purification, which encouraged healing and decreased inflammation, Group A's lack of change may be explained by 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 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 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 wound site, and enhancing oxygen supply. This is where mechanotransduction—a key process—comes into play. Mechanotransduction is conversion of a mechanical stimulus into a biochemical response within cells. In context of wound healing, mechanical forces from actions like massage stimulate cells, prompting signalling pathways that enhance tissue repair and regeneration¹¹. Studies show that massage acts as an immune modulator, influencing neutrophils' apoptotic signalling, reducing release of proinflammatory cytokines¹², and promoting tissue repair. Additionally, mechanical pressure during massage increases local temperature, improving blood flow by relieving vasoconstriction and carrying essential nutrients, oxygen, and insulin to wound site. This improved circulation aids in alleviating anoxic condition of wound. Mechanotransduction also promotes release of beta-endorphins, which provide pain relief¹³. With improved blood flow and nutrient delivery, epithelial cell regeneration is accelerated, leading to faster healing of 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.

with Group B demonstrating superior results. No adverse effects were reported in either group. The study supports the hypothesis that Vimlapana Karmaprovides 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.

During Jalaukavacharana

After treatment

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/s13643-021-01697-3. PMID:33980324; PMCID:PMC8117489.

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. 28th ed. Boca Raton: CRC Press, Taylor & Francis Group; 2023.

5. Bland KI, Sarr MG, Wong J. Principles of Surgery. 10th ed. New York: McGraw-Hill Education; 2012. p. 264.

6. Acharya S, editor. Sushruta Samhita with Nibandha Sangraha commentary of Sri Dalhanacharya. 6th 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.