| CTRI Number |
CTRI/2026/03/105302 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study on Ayurvedic Oil (Shothshardul Taila) in Managing Pilonidal Sinus |
|
Scientific Title of Study
|
A Clinical Exploratory Study To Evaluate The Efficacy Of Shothshardul Taila In The Management Of Nadi Vrana W.S.R To Pilonidal Sinus(PNS) |
| Trial Acronym |
Shothashardul Taila in Pilonidal Sinus |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul kumar |
| Designation |
MS Scholar |
| Affiliation |
PGIA JODHPUR |
| Address |
PG Department of Shalya Tantra Post Graduate Institute of Ayurved Jodhpur, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Karwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India
DSRRAU Karwar Jodhpur-342037
Jodhpur
RAJASTHAN
301001
India |
| Phone |
6375416323 |
| Fax |
|
| Email |
rahulkumarmeena72485@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu dutt sharma |
| Designation |
MS , PHD Shalya Tantra |
| Affiliation |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of shalya tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
Ayurvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu dutt sharma |
| Designation |
MS ,PHD, Shalya Tantra |
| Affiliation |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of shalya tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
Ayurvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN 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 |
| Dr Rahul Kumar |
Post Graduate Institute of Ayurved, Jodhpur |
PG Department of Shalya Tantr Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN |
6375416323
rahulkumarmeena72485@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shothashardul taila, Reference: Bhaishajya Ratnavali ch 42, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 1 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20-60 years
2. Gender: both male and female.
3. Patients with signs and symptoms of Nadivrana (PNS) mentioned in the literature.
4. Patients who will physically fit for anaesthesia and surgical procedures.
5. Patient who will be willing to participate in the study.
6. Patient who willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Unstable patients.
2. HIV
3. Immune deficiency syndrome.
4. Uncontrolled diabetes mellitus.
5. Immunosuppressive medications.
6. Previous participation in trial.
7. Any malignancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Shothshardul Taila on complete Healing of Nadivrana (Pilonidal Sinus). |
2 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To See Other Effect in Subjective Parameters Drug and Procedure |
2 month |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2026 |
| 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
|
N0 |