| CTRI Number |
CTRI/2026/02/103007 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study Comparing Minimal Invasive Kshar Karma Technique with Surgical Excision in Sacrococcygeal Pilonidal Sinus |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the outcome of Minimal Invasive Kshar Karma Technique (MIKKT) with Surgical Excision in managment of Shalyaj Nadi Vrana w.s.r. to Sacrococcygeal Pilonidal Sinus |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Vijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt.Ayurvedic College And Hospital Paprola H.P. |
| Address |
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
Nil |
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfVijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt.Ayurvedic College And Hospital Paprola H.P. |
| Address |
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfVijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt.Ayurvedic College And Hospital Paprola H.P. |
| Address |
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Principal office,Admin block,Rajiv gandhi govt.Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt.Post Graduate Ayurvedic College and hospital H.P. Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt.Ayurvedic College and hospital H.P. Kangra Himachal Pradesh 176115 |
| Address |
Rajiv Gandhi Govt.Ayurvedic College and Hospital H.P.
Kangra Himachal Pradesh 176115 India |
| Type of Sponsor |
Government 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 |
| ProfVijay Chaudhary |
Rajiv Gandhi Govt.Ayurvedic College And Hospital Paprola H.P. |
OPD105,Shalya Tantra dept.,Rajiv Gandhi Govt. Post Graduate Ayurvedic College and hospital H.P.
Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
09418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commttiee,Rajiv Gandhi Govt. Post.Graduate Ayurvedic College and Hospital ,Paprola ,Kangra (H.P.)176115 India |
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 | Intervention Arm | Procedure | - | क्षारकर्म | (Procedure Reference: Sushruta Sutrasthan 11/9, Procedure details: Informed & written consent of the patient & attendant will be taken. Preparation of operative field will be done by means of shaving, cleaning & painting.Under full aseptic condition patient placed in prone position on O.T. table & part will be cleaned with antiseptic solution. After all precautionary measures core excision of sinus tract will be done followed by application of Apamarg Kshar for 100 Matrakala & then washed with Amla drav. Post operative wound dressing will be done with Jataydi Tail until complete epithelialization of wound.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Surgical Excision | Informed and written consent of the patient and attendant will be taken. Under full aseptic conditions patient will be prepared and draped. Under full aseptic condition patient will be placed in prone position on O.T. table and part will be cleaned with antiseptic solution. After all precautionary measures excision of sinus tract will be done and packed with gauze pad. Post operative wound dressing will be done with Jatyadi Tail until complete epithelialization of wound. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary or recurrent sacrococcygeal pilonidal sinus irrespective of gender
Patients who have given written and informed consent.
Patients age group of 18-50 year
|
|
| ExclusionCriteria |
| Details |
If patients fail to adhere to protocol requirement.
Patients of pilonidal sinus with deep structure (bony) involvement .
If Patients is with uncontrolled diabetes, malignancy, tuberculosis.
HIV, HBsAg, HCV positive patients.
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Minimal Invasive Kshar Karma Technique with surgical excision in Shalyaj Nadi Vrana w.s.r. to sacrococcygeal pilonidal sinus |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the different parameters of healing process in post operative wound healing.
To study and compile the Ayurvedic and modern literature concerning the sacrococcygeal pilonidal sinus |
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial is in the early phase and is not yet started. Kshar karma technique is a treatment modality mentioned in sushruta shamita for nadi vrana .I would like to publish my research work after completion of the trial as soon as possible. Pateints will be selected from OPD/IPD of RGGPG Ayurvedic college and hospital paprola,2 groups of 30 patients will be registered and assessed to evaluate the effect of minimal inavasive kshar karma technique in shalyaj nadi vrana reference to sacrococcygeal pilonidal sinus. |