A Clinical Study to Evaluate The Healing Effect of Karanjadi Ghritha Topically in Ksharadagdha Vrana of Low Anal Fistula

Introduction

Fistula-in-ano is a common anorectal condition characterized by an inflammatory track lined with unhealthy granulation tissue, connecting an external opening in the perianal skin to an internal opening in the anal canal or rectum [1]. It is more prevalent in men than women, with incidence rates of 12.3 and 5.6 cases per 100,000, respectively [2]. Fistula-in-ano is classified as low-level and high-level, based on the location of the internal opening relative to the anorectal ring. Low-level fistulas are more common in young adult males, with a male-to-female ratio of 2:1 [3]. Surgical interventions such as fistulectomy, fistulotomy, and techniques like LIFT and seton placement are commonly employed [4].

In Ayurveda, this condition is correlated with Bhagandhara, one of the Ashtamahagada vyadhis. Classical Ayurvedic texts describe Bhagandhara as tearing (dharana) the bhaga, guda, and vasthi pradesha [5]. The treatment often involves excision followed by ksharakarma or agnikarma, with wound-healing agents applied post-procedure. Karanjadighritha, mentioned in Susrutha Samhitha Vidradhichikitsadhyaya, is noted for its healing properties, specifically for ksharadagdhavrana. This study evaluates the topical application of Karanjadighritha in the healing of low-level anal fistulas post-ksharakarma.

Aim and Objectives:

Aim:
To evaluate the topical application of Karanjadighritha in the management of ksharadagdhavrana in low anal fistulas.

Objectives:

1. To assess the healing effect of Karanjadighritha on clinical parameters such as pain, granulation tissue formation, and tract length reduction.
2. To evaluate its efficacy in promoting wound healing in ksharadagdhavrana.

Materials and Methods:

Study Design:

This single-group, pre-and-post interventional study evaluated the healing effect of Karanjadighritha on low anal fistulas.

Study Setting:

The study was conducted in the OPD and IPD of the Department of Salyatantra, Govt. Ayurveda College Hospital, Thiruvananthapuram.

Study Population:
Participants aged 20–70 years with low anal fistulas meeting inclusion criteria were recruited.

Inclusion Criteria:

1. Diagnosed low anal fistula confirmed by MRI with a tract length <5 cm.
2. Ksharadagdhabhagandharavrana (wounds caused by ksharakarma).

Exclusion Criteria:

1. Congenital anal fistulas.
2. Patients with systemic diseases like uncontrolled diabetes, Crohn’s disease, and CA rectum.

Intervention:

Post-ksharakarma, Karanjadighritha was applied topically over the wound daily for 42 days. Participants were evaluated at 7-day intervals.

Outcome Measures:

1. Pain and burning sensation (assessed using visual analog scales).
2. Granulation tissue formation (clinical examination).
3. Tract length reduction (measured using a malleable copper probe).

Sample Size:
A total of 25 participants were recruited using consecutive sampling.

Statistical Analysis:
Results were analyzed using paired t-tests, with significance set at p<0.05.

DETAILS OF INTERVENTIONAL DRUG

Name of the Drug: Karanjadighritha

 Table 1: Ingredients of Karanjadighritha

Preparation of the Drug

Karanjadighritha is prepared as per classical Ayurveda texts by a GMP-certified manufacturer.

Intervention

Purvakarma

• Informed consent was obtained.
• Under aseptic conditions, the fistulous tract was laid open, and Apamarga prathisaraneeya kshara was applied using a spatula.
• Upon achieving samyak ksharadagdha lakshanas, the wound was washed with nimbu swarasa.
• The wound was cleaned thoroughly using sterile cotton.

Pradhana Karma

• Karanjadighritha was taken according to the size of the wound.
• The ghrita was applied over the ksharadagdhavrana as a varthi.
• Dressing was done using a sterile pad and adhesive plaster.

Paschath Karma

• The participant was advised to rest until stable.
• Dressing was changed the next morning.

Assessment Period

• The assessment period lasted 42 days.
• Dressing was repeated daily, and assessments were conducted on the 0th, 7th, 14th, 21st, 28th, 35th, and 42nd days.
• Participants were advised daily sitz baths with lukewarm saline water until complete wound healing.
• Brihat Triphala Churnam (10 g) with hot water at bedtime was given until the wound healed.

Outcome Measures

The treatment’s efficacy was assessed using subjective and objective parameters based on clinical observations.

Subjective Parameters

1. Pain (assessed using Visual Analogue Scale):

1. • 0: Absent
   • 1–3: Mild
   • 4–6: Moderate

• >7: Severe

2. Burning Sensation:

1. • 0: Absent
   • 1: Mild
   • 2: Moderate
   • 3: Severe

Objective Parameters

1. Granulation Tissue:

1. • 0: Healthy
   • 1: Moderate
   • 2: Unhealthy
   • 3: Absent

2. Length of the Tract:

1. • Length was measured along the long axis using a malleable copper probe.

Average Healing Rate per Week = Initial length of the tract ÷ Number of weeks to heal

Data Analysis

The data related to both subjective and objective parameters of 25 participants were analyzed statistically. The results were evaluated using the Wilcoxon Signed-Rank Test.

Observation and Results

Pain (VAS Scale)

The Pain VAS Scale statistics indicate a significant reduction in pain over a 42-day period. Initially, on Day 0, the mean pain score was 9.00 (SD = 1.00) with a median of 9, reflecting high pain levels among participants. By Day 7, the mean score decreased to 5.52, and by Day 42, it further reduced to 0.08. The Wilcoxon Signed-Rank Test showed statistically significant reductions in pain, with all p-values being <0.001. These results strongly support a substantial and statistically significant decrease in pain levels over the study period.

Burning Sensation

The Burning Sensation Scores showed a significant reduction from Day 0 to Day 42. On Day 0, the mean score was 3 (SD = 0), indicating all participants reported the highest burning sensation score. By Day 7, the mean score dropped to 1.88 and progressively decreased to 0.04 by Day 42, indicating almost complete resolution. The Wilcoxon Signed-Rank Test yielded z-scores ranging from 4.444 to 4.914, with all p-values <0.001, highlighting a consistent decrease in burning sensation throughout the study period.

Granulation Tissue Formation

Initially, on Day 0, there was no granulation tissue. From Day 7 onward, healthy granulation tissue was observed across all participants, and this improvement was sustained through Day 42. The Wilcoxon Signed-Rank Test results (z-score = 5.000, p-value <0.001) confirm a rapid and significant improvement in tissue health within one week, maintained throughout the study.

Length of the Tract

The tract length showed a significant reduction over the 42-day study period. By Day 7, the mean tract length decreased to 2.12, with further reductions observed weekly, reaching 0.02 by Day 42. The Wilcoxon Signed-Rank Test results demonstrated highly significant reductions in tract length across all time points (p-values <0.001), reflecting the effectiveness of the intervention.

Table 2: Incidence of Demographic Factors

Table 3: Effectiveness of Treatment on Clinical Responses

Discussion

In the present study, 25 patients with low anal fistula were selected based on the inclusion criteria, and their outcomes were evaluated after treatment with karanjadighritha.

Demographic Insights

The age distribution indicates that most participants (60%) were within the 31–50 age range, with 28% in the 31–40 group and 32% in the 41–50 group. This finding suggests that middle-aged individuals are more susceptible to anal fistulas. Younger participants (21–30 years) had faster wound healing, consistent with the established understanding that wound healing is more efficient in younger individuals due to better cellular activity [22]. Gender analysis revealed a significant male predominance (84%), aligning with previous studies highlighting the higher prevalence of fistulas in men.

Domicile data showed that 60% of participants resided in urban areas, while 40% were from rural regions. Urban residents are more likely to have dietary habits contributing to constipation, a risk factor for anal fistulas. Non-vegetarian diets were prevalent among 96% of participants, with only 4% following a vegetarian diet. A low-fiber, non-vegetarian diet can impair jadaragni and lead to agnimandhya, a known nidana for bhagandhara. Additionally, 84% of participants reported constipation, emphasizing the strong correlation between bowel habits and the development of anal fistulas.

Occupational analysis revealed that 68% of participants engaged in sedentary work, such as prolonged sitting, which is a contributing factor to fistula formation. Appetite patterns further supported the role of agnimandhya, as 72% of participants had reduced appetite, indicating poor jadaragni. Addictions such as alcohol consumption and smoking, reported by the majority, are known to impair wound healing by suppressing immune responses and delaying inflammatory and proliferative phases of healing [23].

Probable Mode of Action of Karanjadighritha

Effective wound healing requires the removal of dushti and maintaining a shuddha vrana. During ksharakarma, the ksharana property of kshara eliminates unhealthy granulation tissue and fibrous tissue from the fistula tract. The laghu and tikshna guna of karanjadighritha aid in cleansing the wound, while the tikta and kashaya rasa of its ingredients, combined with the visada guna, help remove slough.

The pittahara properties of karanjadighritha reduce inflammation, addressing symptoms like redness, pain, and burning sensation. Active compounds such as curcumin in haridra, alkaloids in karanja and nimba, and flavonoids in jati contribute to antimicrobial and anti-inflammatory effects. Additionally, tannins and phytosterols in haridra, yashti, utpala, and sariva enhance capillary formation, fibroblast proliferation, and epithelialization. The yogavahi guna of ghrita improves drug penetration, expediting wound healing [24].

Outcome Variables

Effect on Pain

Pain levels significantly decreased throughout the study. The vatanashaka properties of madhuka, sariva, and goghrita alleviated pain, while the chedana and lekhana properties of karanja, jati, patola, manjishta, and daruharidra ensured the removal of unhealthy granulation tissue, preventing pus formation. The visada guna of kashaya rasa helped clear wound slough and reduce infection, further contributing to pain relief.

Effect on Burning Sensation

All participants reported severe burning sensations immediately after ksharakarma, which progressively reduced with the application of karanjadighritha. This effect is attributed to the pittahara properties of the formulation, along with the sheeta virya, soumya guna, and madhura vipaka of ingredients such as madhuka, chandana, ushira, sariva, and utpala. These properties collectively facilitated the dahaprasamana of the wound.

Effect on Granulation Tissue Formation

Healthy granulation tissue formation was observed within the first week of treatment and was sustained throughout the study. This rapid transition highlights the effectiveness of karanjadighritha in promoting tissue healing. The laghu guna of jati, nimba, patola, haridra, daruharidra, chandana, and ushira supported wound cleansing. Additionally, the tikta-kashaya rasa and lekhana and chedana properties of kashaya rasa removed slough, while the ushna virya of certain ingredients improved circulation, facilitating healthy granulation tissue development.

Effect on Length of the Tract

The study demonstrated a significant reduction in the length of the fistula tract, with healing nearly complete for most participants by Day 42. The kashaya-tikta rasa of the formulation’s ingredients facilitated ropanakarma through their sandhaniya properties. Constituents like tannins and phytosterols enhanced capillary formation and fibroblast proliferation, promoting epithelialization and wound contraction. Notably, one participant’s wound remained unhealed due to anemia (Hb 10.8 g%), indicating the influence of systemic factors on wound healing.

Conclusion

The findings of this study demonstrate that karanjadighritha is highly effective in managing ksharadagdhavrana in low anal fistulas. The topical application of karanjadighritha significantly reduced pain and burning sensation, shortened the length of the wound, and promoted the formation of healthy granulation tissue, thereby accelerating the wound healing process. This highlights its therapeutic potential as a supportive intervention in fistula management.

The study’s results are statistically highly significant, providing strong evidence that karanjadighritha plays a vital role in enhancing the natural wound healing process. Furthermore, no adverse events were reported during the study period, indicating the safety of the formulation for clinical use.

Thus it can be said that, while wound healing is an inherent biological process, the application of karanjadighritha provides a valuable enhancement to this process. This study reinforces the efficacy and safety of karanjadighritha in promoting wound healing and supports its integration into the management of bhagandhara and similar conditions.

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