Anal Fistula management with Standardized Ksharasutras

Phase 3

Suspended

• Conditions: Disease of anus and rectum, unspecified, ,

• Registration Number: CTRI/2018/08/015236
• Lead Sponsor: JS AYURVED MAHAVIDHYALAYA NADIAD

Brief Summary

*Bhagandara* is one among the eight *Mahaagadas* described by *Maharshi Sushruta. Acharya Sushruta* has mentioned that all types of *Bhagandara* are difficult to treat. In modern medicine, a fistula-in-ano is an abnormal communicating tract between anal canal and peri-anal skin. It is also known for its significant risk of recurrence (0.7–26.5%) and high risk of impaired continence (5–40%) in modern surgery. Basing upon the clinical manifestations, fistula in ano can be correlated with *Bhagandara* clinical entity described by *Acharya Sushruta.**Ksharsootra* is a very well -known alternative therapy for the management of Fistula-in-ano.In present study, *Snuhi* *Kshara* isselected on the basis of its *Tikshna* property to evaluate their clinical efficacy in fistula-in-ano and classical *Snuhi* *Ksheera* based *Ksharsootra* to evaluate its clinical efficacy in the management of fistula in ano. The Indian Council of Medical Research (ICMR) has validated it and WHO has accepted the effectiveness of this an Ayurvedic treatment modality in treating fistula in ano. So, Standardization of *Kshara* and *Ksharsootra* are prime need before their clinical application. This study has been planned for standardization of *Snuhi* *Kshara*, *Ksharsootra* and their comparative clinical assessment in the management of *Bhagandara* (fistula-in-ano).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-21
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1 All types of low anal fistula in ano (Vataja, Pittaja, Kaphaja, Vata-Pittaja, Vata-Kaphaja and Arsho-Bhagandara (Kapha-Pittaja) 2Fistula in ano with controlled TB, DM, Hypertension.

Exclusion Criteria

• 1Sannipaataja and Agantuja Bhagandara 2Fistula other than fistula-in-ano.
• 3High anal fistula in ano.
• 4Fistula associated with uncontrolled TB, DM, Hypertension or Osteomyelitis, Venereal Disease, Pregnancy, Chronic or acute ulcerative colitis, Crohn’s disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in sign and symptoms of fistula in ano and complete cure	30 to 60 days

Secondary Outcome Measures

Name	Time	Method
Optimum working device from two types of ksharasutra in the management of fistula in ano by Ayurved	30 to 60 days

Trial Locations

Locations (2)

JS Ayurved Mahavidyalay and PD Patel Ayurved Hospital Nadiad Gujarat India; 🇮🇳 Kheda, GUJARAT, India

OPD SHALYATANTRA 136; 🇮🇳 Kheda, GUJARAT, India

JS Ayurved Mahavidyalay and PD Patel Ayurved Hospital Nadiad Gujarat India

🇮🇳Kheda, GUJARAT, India

Dr Foram Joshi

Principal investigator

9924468211

dr.foramj@gmail.com