Clinical study to compare the effect of modified apamarga kshaara sutra and standard apamarga kshaarasutra in the management of bhagandara (fistula-in-ano)
- Conditions
- Anorectal fistula. Ayurveda Condition: BAGANDARAH,
- Registration Number
- CTRI/2023/08/056968
- Lead Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan
- Brief Summary
*Bhagandara* is second common disease occurring in ano-rectal region after haemorrhoids. The prevalence rate of fistula-in-ano is 8.6 cases per 1 lakh population. The prevalence in men is 12.3 and in women is 5.6 cases per 1 lakh population. The male-to-female ratio is 1.8:1. The mean age of participants is 38.3 years. It is considered as one among the *Mahagada* in *Sushruta Samhita*. In *Ayurveda Kshaarasutra* application is well known for management of *Bhagandara.*
**Advantages of** ***Kshaara Sutra*** **Therapy****:** Simple and safe parasurgical procedure, cost-effective and ambulatory, minimal recurrence rate, no surgical complications like incontinence, stenosis and stricture. *Snuhi Ksheera* based *Apamarga Kshaarasutra* is the standard one and is proved effective treatment in the management of Fistula-in-ano. Delays in unit cutting time of the fistulous tract and difficulty of manufacturing process has limited its use.
At present Apamarga Kshaarasutra is prepared by giving 11 coatings of *Snuhi* *ksheer*, 7 coatings of *Snuhi* and Apamarga Kshaara and 3 coatings of *Snuhi* and Haridra which takes a total of 21 days for preparation of the Standard *Apamarga Kshaarasutra*. In the current study,
**PROBLEMS-**
**Collection of raw material –** Collecting *Snuhi Ksheer* for 21 days is a problem for a practicing Doctor and its less availability.
**Weakening of** ***Kshaara Sutra*** – As the day increases the thread used for *Kshaara Sutra* (tensile strength of thread)gets weak day by day hence I am trying to keep the strength of thread as stronger as possible which will reduce the changing time for participants also and benefits them in the way pain of *Kshaara Sutra* changing and reduces the financial load to participants.
To overcome these problems, I have adopted the study of Modified *Kshaara Sutra* in the management of *Bhagandhara*
**SOLUTIONS**
As the modified *Kshaara Sutra* is less exposed to heat and its tensile strength is preserved it may decrease the unit cutting time.
Which will be beneficial to participants in the manner of frequent pain of *Kshaara Sutra* changing and financially also
*Apamarga Kshaarasutra* is prepared out of 11 coatings of *Snuhi* *ksheer*, 3 coatings of *Snuhi* *Apamarga Kshaara* and 3 coatings of *Snuhi* and *Haridra*, so a total of 21 coatings will be given.This study has been intended to evaluate whether 21 coatings in 7 days of modified *Kshaara sutra* is effective in comparison to standard *Apamarga Kshaarasutra* in terms of decreased time period of preparation and to assess the unit cutting time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Clinical signs and symptoms of all types of Bhagandara Recurrent Fistula- in-ano Fistula- in-ano with Perineal abscess Participants who give written surgical consent Participants fit for surgery Participants above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.
Participants with secondary fistula due to Ulcerative colitis, Crohn’s disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal Participants with HIV and HBsAg 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 of Fistulous tract 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, granulation tissue, size of wound assessment will be done at baseline followed by weekly assessment until the fistula tract is completely healed.
Trial Locations
- Locations (1)
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
🇮🇳Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan🇮🇳Hassan, KARNATAKA, IndiaDr Saurabh Kumar YadavPrincipal investigator6360271762ysaurabh920@gmail.com