| CTRI Number |
CTRI/2023/06/053996 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison in kshar sutra ligation & chedan karm in pilonidal sinus |
|
Scientific Title of Study
|
Comparitive clinical study of kshara sutra ligation and chedan karma in the management of Nadi vrana W.S.R. to 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 Mandar Taru |
| Designation |
Professor |
| Affiliation |
Vaidya yagya dutt sharma ayurved mahavidyalay |
| Address |
OPD NO. 5 , Vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8055933901 |
| Fax |
|
| Email |
mandartaru786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandar Taru |
| Designation |
Professor |
| Affiliation |
Vaidya yagya dutt sharma ayurved mahavidyalay |
| Address |
OPD NO. 5 , Vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8055933901 |
| Fax |
|
| Email |
mandartaru786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeet Kumar Sahu |
| Designation |
P.G. Scholar |
| Affiliation |
Vaidya yagya dutt sharma ayurved mahavidyalay |
| Address |
OPD NO. 5 , Vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8960580421 |
| Fax |
|
| Email |
drsanjeetsahu621@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya yagya dutt sharma Ayurved mahavidhyalaya,khurja, up |
|
|
Primary Sponsor
|
| Name |
Sanjeet kumar sahu |
| Address |
OPD NO. 5 , Vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanjeet kumar sahu |
Vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP |
Opd no 5 Shakya tantra department vaidya yagya dutt sharma ayurved maha vidyalaya, khurja ,bulandshahr, UP
Bulandshahar
UTTAR PRADESH |
8960580421
drsanjeetsahu621@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Su. Ch. 17/30-33, Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients who presented with the signs & symptoms of Nadi Vrana
W.S.R. to Pilonidal Sinus
Sex - Both Male & Female included in these clinical trials.
Symptoms - Pain, Swelling. Discharge and Discoloration
Single Sinus track situated at midline of natal cleft.
Patients willing to undergo clinical trial |
|
| ExclusionCriteria |
| Details |
Patients aged below 18 and above 60 years of age
Patients who are sensitive to Xylocaine will be excluded
Pilonidal sinus more than 6 cm in length
Lateral opening and Multiple sinus
Systemic diseases like Diabetic mellitus, tuberculosis will be excluded.
Malignant condition
Patients unfit for Surgical excision and Ksharasutra Ligation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kshar sutra is better then chedan karma |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chedan karam takes less but has more reoccurance rate then kshar sutra or not |
3 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kshar sutra is one of the best treatment mentioned by sushrut for the treatment of pilonidal sinus and here we are comparing it with chedan karm in pilonidal sinus. There is more reoocurance rate in chedan karm so i wanna prove that kshar sutra is much better treatment for pilonidal sinus. So that patients can get permanent relief. |