A clinical trial to study two ksharasutra, kutaja ksharasutra and apamarga ksharasutra in patient with bhagandra ( fistula-in-ano)

Not yet recruiting

Conditions: Anorectal fistula. Ayurveda Condition: BAGANDARAH,

Registration Number: CTRI/2025/04/084054

Lead Sponsor: Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan

Brief Summary: Bhagandara is the second common disease occurring in ano-rectal regionafter Arshas. The prevalence rate of fistula-in-ano is8.6 cases per1lakh population.Estimatessuggest that it affects approximately 0.05% to 0.1%of the general population in India. The prevalence in men is 12.3 casesper 1 lakh population and in women is 5.6 cases per 1 lakh population. Themale-to-female ratio is 1.8:1. The mean age of participants is 38.3 years. Itis considered as one among the

Mahagada in Sushruta Samhita.

In AyurvedaKshara Sutra application is well known in the management of Bhagandara. Advantagesof KsharaSutra Therapy**:** Simple and safeparasurgical procedure,cost-effective and ambulatory, minimal recurrence rate,no surgical complications like incontinence, stenosis and stricture..

Atpresent Apamarga Ksharasutra is prepared by giving 11coatings of SnuhiKsheera,7coatings of Snuhi and Apamarga Kshara and 3 coatings ofSnuhiandHaridrawhichtakesatotalof21daysforpreparation of the Apamarga Kshara Sutra.

AcharyaSusruta ,while describing the process of Kshara extraction in sutrasthana chapter-11has mentioned 23 drugs and Kutaja is first and foremost drug. Acharya Sushrutain the 17th chapter of SushrutaChikitsaSthanahasadvocatedtheKsharaSutraanditsapplication.Chakrapanidattahasdescribed the preparation of Kshara Sutra by smearing the latex of Snuhi,Kshara and Haridra repeatedly.

Inthe current study the potential synergistic effect of comparing Apamarga KsharaSutra, known for its healing qualities of the fistulous tract but its demeritssuch as irritation and burning sensation during primary and successive changesand also local skin irritation occurs during course of therapy and it is only *Kaphahara* to overcome these with *Kutaja Kshara Sutra*, where *Kutaja* possesses qualities like *Kaphapitta Doshahara* and has *Sheeta Virya*, which merit further studyto assess the potential of *Kutaja KsharaSutra* against the demerits of *ApamargaKshara Sutra.*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Clinical signs and symptoms of all types of Bhagandara Fistula- in-ano with Perianal abscess Participants who give written surgical consent Participants fit for surgery Participants above the age of 18 years and below 60years irrespective of caste,gender, religion and socio-economic status.

Exclusion Criteria

Participants with secondary f istula due to Ulcerative colitis, Crohns disease,Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal ,condyloma acuminata,condyloma lata Participants with HBsAg and retro positive participants.
Pregnancy and lactating women.
Participants with impaired cardiac, renal and hepatic function.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
unit cutting time of fistulous track	assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Secondary Outcome Measures

Name	Time	Method
pain	discharge

Trial Locations

Locations (1): Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
🇮🇳
Hassan, KARNATAKA, India
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
🇮🇳Hassan, KARNATAKA, India
Dr Pooja B D
Principal investigator
9686934295
pooja10aaglecha@gmail.com