A comparative study of healing effect of Panchatikta ghrita guggulu and Shigru Guggulu in fistula in ano with partial fistulotomy and Ksharsutra application - A randomised controlled trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Complete uneventful healing of the fistulotomy wound
Study Overview
Brief Summary
Fistula in ano is a very difficult disease to tackle and cure. Ksharsutra therapy provides a ray of hope to the suffering humanity as it ensures minimal invasion and minimal recurrence rates. The healing after partial fistulotomy and ksharsutra application has been an issue on account of contamination in the wound. The wound healing can be augmented by using Panchtikta Ghrita Guggulu as an oral drug in these patients. The Shigru guggulu has been in use post operatively in these cases. Panchatikta ghrita guggulu is a potent drug for the use in various dermatosis and it can be studied in comparison to Shigru guggulu. The dose shall be same for both drugs and that is 500 mg twice a day for 30 days. The patients shall be selected from OPD and IPD of department of Shalya tantra, All India Institute of Ayurveda and the groups shall be allocated on random basis. Shigru Guggulu shall be the control. Statistical calculations shall be carried out in terms of mean (x), SD, SE, Z test and finally the results shall be incorporated in terms of probability (p)
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of Primary Fistula in ano (Cryptoglandular infection) of either gender.
Exclusion Criteria
- •1 Secondary Fistula in ano 2 Age below 18 years and above 60 years 3 Severe anaemia 4 Anorectal carcinoma 5 Osteomyelitis 6 Inflammatory bowel disease 7 Pregnancy 8 Diabetes mellitus 9 Tubercular fistula in ano 10 Hypertension 11 HIV HBsAg and HCV positive patients 12 patients who are not willing to part of study.
Outcomes
Primary Outcomes
Complete uneventful healing of the fistulotomy wound
Time Frame: First week, first month, Second month, Third month
Secondary Outcomes
- good scar without any hypertrophy(three months)