| CTRI Number |
CTRI/2021/11/037853 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
03/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Difference between standard kshar sutra and udumber(cluster fig) ksheer sutra in treatment of pilonidal sinus. |
|
Scientific Title of Study
|
Comparative study of efficacy of Standard Kshar Sutra and Udumber Ksheer Sutra in the management of Naadi Vrana (Pilonidal Sinus). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshadkumar Sukhdevbhai Prajapati |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Room no 13 Department of Shalya Tantra Mahatma Gandhi
Ayurvedic college and Hospital and research centre Salod Hirapur
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8155088742 |
| Fax |
|
| Email |
harshadprajapati0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Khandare |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Room no 13 Department of Shalya Tantra Mahatma Gandhi
Ayurvedic college and Hospital and research centre Salod Hirapur
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765033585 |
| Fax |
|
| Email |
kbkhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Khandare |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Room no 13 Department of Shalya Tantra Mahatma Gandhi
Ayurvedic college and Hospital and research centre Salod Hirapur
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765033585 |
| Fax |
|
| Email |
kbkhandare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Science |
| Address |
Mahatma Gandhi Ayurvedic college hospital and research centre
Salod Hirapur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshadkumar Sukhdevbhai Prajapati |
Mahatma Gandhi Ayurvedic college hospital and research centre |
Room no 13 Department of Shalyatantra Mahatma Gandhi Ayurvedic college hospital and research centre
Salod Hirapur Wardha
Wardha
MAHARASHTRA |
8155088742
harshadprajapati0001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L050||Pilonidal cyst and sinus with abscess. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | KSHEER SUTRA APPLICATION | (Procedure Reference: SUSHRUTA SAMHITA, Procedure details: UNDER LA/SA DRAINING OF PUS AND REMOVE DEBRIES AND HAIR FROM PILONIDAL SINUS AND UDUMBER KSHEER SUTRA LIGATION DOING.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing with consent
Patient with age group of 18 to 60 years
Patients with diagnosed Naadi Vrana Pilonidal Sinus will be included after screening
Patients irrespective of sex occupation and economic status will be included |
|
| ExclusionCriteria |
| Details |
Patients suffering with systemic disorders like Diabetes mellitus Tuberculosis HIV and Hepatitis will be excluded
Patients having Malignancy will be excluded
Pregnant or lactating women |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•As the Udumber Ksheer Sutra is easily available in nature and cost effective.
•Less painful, reduction in unit cutting time and will have better wound healing properties.
•Might replace widely used different types of Kshar Sutras in Naadi Vrana (Pilonidal Sinus). |
1st 2nd 3rd 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • If Udumber Ksheer Sutra proved to be more effective in management of Naadi Vrana (Pilonidal Sinus) as compare to Standard Kshar Sutra then it will provide more acceptable as well as convenient treatment. |
5th 6th week
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study the patients will be informed about the study protocol. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACH & RC, Salod(H), Wardha Than selection of each patients according to selection criteria. They are divided into 2 groups. In 1 group (18 patients) we will give Standard KShar Sutra therapy and in another group (18 Patient) we will give Udumber Ksheer Sutra therapy applied in Naadi Vrana (Pilonidal Sinus) every week for 4 weeks after 28-30 days. Assessment will be done in
the basis of subjective and objective criteria to rule out which Sutra is more effective in the treatment
of Naadi Vrana (Pilonidal Sinus). |