A clinical trial to study the effects of two ksharasutras, asphota ksharasutra and apamarga ksharasutra in patients with low anal fistula.

Randomized controlled trial on the efficacy of asphota ksharasutra against apamarga ksharasutra in low anal fistula.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043614

Enrollment

Registered

2022-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K603- Anal fistula

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both Male and Female participants in the age group of 20 years to 60 years will be enrolled. 2. Participants who have low anal fistula with single tract diagnosed by clinical examination 3. Participants with written informed consent

Exclusion criteria

Exclusion criteria: 1. Participants below 20 years of age and above 60 years of age 2. Participants with uncontrolled diabetes mellitus and hypertension 3. Known HIV/hepatitis B/VDRL positive participants will be excluded 4. Known colorectal carcinoma patients 5. Known ulcerative colitis patients 6. Known patients with Crohns disease 7. Known patients with tuberculosis

Design outcomes

Primary

Measure	Time frame
Unit Cutting Time of the ksharasutra measured by the formula (Initial length of ksharasutra in cm/Total no of days for cut through) and healing effect of ksharasutra assessed by epithelialisation (time taken to form a scar after ksharasutra cut through) Timepoint: 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day, 49th day, 56th day, 63rd day, 70th day, 77th day and 84th days for assessing Unit Cutting Time. For assessing healing effect, 0th day will also be considered (Day of application of the ksharasutra)	—

Measure

Time frame

Unit Cutting Time of the ksharasutra measured by the formula (Initial length of ksharasutra in cm/Total no of days for cut through) and healing effect of ksharasutra assessed by epithelialisation (time taken to form a scar after ksharasutra cut through) Timepoint: 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day, 49th day, 56th day, 63rd day, 70th day, 77th day and 84th days for assessing Unit Cutting Time. For assessing healing effect, 0th day will also be considered (Day of application of the ksharasutra)

—

Secondary

Measure	Time frame
Effect of ksharasutra in discharge, burning sensation and pain.Timepoint: 0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day, 49th day, 56th day, 63rd day, 70th day, 77th day and 84th days.	—

Countries

India

Contacts

Public ContactDr M M Abdul Shukkoor

Government Ayurveda College, Tripunithura, Ernakulam

drsukoor@gmail.com9447661001

Outcome results