A clinical trial to Study on the effects of two medicated threads,thuttakadi sutra and apamarga ksharasutra in bhagandara

Phase 3

Not yet recruiting

• Conditions: Anal fistula. Ayurveda Condition: BAGANDARAH,

• Registration Number: CTRI/2023/05/052240
• Lead Sponsor: Government Ayurveda College Tripunithura Ernakulam

Brief Summary

The trial will be conducted to assess and compare the efficacy of thuttakadi sutra with apamarga ksharasutra in low anal fistula. Thuttakadi sutra will be prepared with medicines of thuttakadi varti is mentioned in Rasa tarangini. The ingredients are nirmalikrta suddha tuttha, kustha churna, triphala churna, daruharidra churna, danti-mula churna, trivrt churna, tila churna, honey, pippali churna, saindhava lavana, nimba dala swarasa. Apamarga ksharasutra will be prepared as per the procedure of making of ksharasutra described by CCRAS standardization. The study will be conducted in participants who are clinically diagnosed with low anal fistula, attending the OP and IP, Department of Salyatantra, Government Ayurveda college, Tripunithura in the age group 18 to 60 years, who satisfy the inclusion and exclusion criteria. Primary outcomes are unit cutting time  assessed by using formula.secondary outcome includes effect of pain, burning sensation, discharge which are assessed based on scale prepared by Paul O Madson and Peter and bleeding is assessed on the basis of its presence or absence.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-28
• Study Start: 2023-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1)Low anal fistula diagnosed by clinical examination will be selected 2)Participants with age group of 18-60 years will be selected 3)Participants selected irrespective of gender, caste, religion and economic status 4)Participants with written consent will be selected.

Exclusion Criteria

• Fistula in known cases of colorectal carcinoma, crohn’s, ulcerative colitis, tuberculosis Uncontrolled diabetes mellitus, Uncontrolled hypertension.
• Known case of HIV, hepatitis B or veneral diseases will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
unit cutting time of the ksharasutra measured by the formula (total number of days for cut through/initial length of ksharasutra (in cms)	Assessment will be done on 0th | day before applying medicated thread then weekly, prior to | change of thread changes up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
effect of medicated thread in pain, burning sensation, discharge, bleeding	assessment will be done on 0th day before applying medicated thread then weakly, prior to change of thread changes up to 12weeks.

Trial Locations

Locations (1)

Government Ayurveda College Tripunithura; 🇮🇳 Ernakulam, KERALA, India

Government Ayurveda College Tripunithura

🇮🇳Ernakulam, KERALA, India

Anagha U

Principal investigator

08921723363

anu.4493@gmail.com