A clinical study to assess cutting and healing effect of apamargadi ksharasutra in patients with pilonidal sinus.

Phase 2/3

Not yet recruiting

• Conditions: Pilonidal cyst and sinus without abscess. Ayurveda Condition: NADIVRANAH,

• Registration Number: CTRI/2022/07/043658
• Lead Sponsor: Government Ayurveda College hospital Tripunithura

Brief Summary

The trial will be conducted to assess the cutting and healing effect of apamargadi  ksharasutra, prepared out of apamarga, palasha, kadalikanda, swarjika kshara and shankhanabhi bhasma  [as per Gada nigraha by Shodala] in pilonidal sinus. The study will be conducted in participants who are clinically diagnosed with pilonidal sinus, attending the OP and IP, Department of Salyatantra, Government Ayurveda College Tripunithura, in the age group 15 to 40 years, who satisfy the inclusion and exclusion criteria. The study duration is till cut through of the pilonidal  tract or till a maximum of 70 days. Primary outcomes are Unit Cutting Time and healing effect out of which the former is assessed by the formula - Total number of days for cut through/Initial length of the ksharasutra in cm and the latter is assessed by measuring length of resultant wound after ksharasutra cut through. Secondary outcomes include effect of this ksharasutra in itching, pain and discharge in the conditions, which are assessed by the grading prepared by Paul O’ Madson and Peter. Primary outcomes except Unit Cutting Time and healing effect are assessed on weekly from 0th day till 70th day and Unit Cutting Time and healing effect will be assessed on the basis of length of ksharasutra and length of resultant wound  after succeeding changes from 7th day onwards till 70th day. Secondary outcomes will be assessed from 0th day (day of application of the ksharasutra) till 70th day.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-07
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Both male and female participants in the age group of 15 years to 40 years will be enrolled.
• Participants who have pilonidal sinus in sacrococcygeal diagnosed by clinical examination.
• Participants with written informed consent/assent.

Exclusion Criteria

• Participants below 15 years of age and above 40 years of age.
• Participants with uncontrolled Diabetes mellitus and Hypertension.
• Known HIV/hepatitis B/VDRL positive participants will be excluded.
• Known patients with tuberculosis.
• Known patients with bleeding disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unit Cutting Time of the ksharasutra measured	7th day, 14th day, 21st day, 28th day, 35th day, | 42nd day, 49th day, 56th day, 63rd day, 70th | days for assessing Unit | Cutting Time. For assessing healing effect, 0th | day will also be considered (Day of application of | the ksharasutra)
by the formula (Total no of days for cut through/Initial length of ksharasutra in	7th day, 14th day, 21st day, 28th day, 35th day, | 42nd day, 49th day, 56th day, 63rd day, 70th | days for assessing Unit | Cutting Time. For assessing healing effect, 0th | day will also be considered (Day of application of | the ksharasutra)
cm) and healing	7th day, 14th day, 21st day, 28th day, 35th day, | 42nd day, 49th day, 56th day, 63rd day, 70th | days for assessing Unit | Cutting Time. For assessing healing effect, 0th | day will also be considered (Day of application of | the ksharasutra)
effect of ksharasutra assessed by measuring length of resultant wound.	7th day, 14th day, 21st day, 28th day, 35th day, | 42nd day, 49th day, 56th day, 63rd day, 70th | days for assessing Unit | Cutting Time. For assessing healing effect, 0th | day will also be considered (Day of application of | the ksharasutra)

Secondary Outcome Measures

Name	Time	Method
Effect of ksharasutra in discharge, itching and pain.	0th day, 7th day, 14th day, 21st day, 28th day,

Trial Locations

Locations (1)

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

Government Ayurveda College Hospital, Tripunithura

🇮🇳Ernakulam, KERALA, India

Mini M S

Principal investigator

8848213949

minimohananm@gmail.com