| CTRI Number |
CTRI/2025/03/082732 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial that will assess that effectivness of Rasanjanadi Lepa in treating Nadi Vrana (Pilonidal Sinus) through a randomised controlled trial. |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of Rasanjanadi Lepa in mangament Of Nadi Vrana (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 |
Dr Sarvagya Pathak |
| Designation |
MS ( Ayurved) Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre , Gangoh-247341. |
| Address |
Kunwar Shekhar Vijendra Ayurveda Medical College and Research Centre, Adarsh Institutional Area,Babu Vijendra Marg ,Shobhit University,Gangoh,Saharanpur
247341.
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8310440564 |
| Fax |
|
| Email |
sarvagyapathak123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnanand.C |
| Designation |
Professor & HOD Shalyatantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre , Gangoh, Saharanpur -247341 |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Adarsh Institutional Area, Babu Vihendra Marg, Shobhit University , Gangoh, Saharanpur,UP-247341
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9360906457 |
| Fax |
|
| Email |
drkrishnanandc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnanand.C |
| Designation |
Professor & HOD Shalytantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre , Gangoh -247341 |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Adarsh Institutional Area, Babu Vihendra Marg, Shobhit University , Gangoh, Saharanpur,UP-247341
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9360906457 |
| Fax |
|
| Email |
drkrishnanandc@gmail.com |
|
|
Source of Monetary or Material Support
|
| 0PD-3, Department of Shalyatantra, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Adarsh Institutional Area, Babu Vijendra Marg, Shobhit University,Gangoh,Saharanpur,UP-247341
|
|
|
Primary Sponsor
|
| Name |
Dr Sarvagya Pathak |
| Address |
OPD-3 ,Department of Shalyatantra, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Adarsh Institutional Area,Babu Vijendra Marg ,Shobhit University, Gangoh , Saharanpur, UP- 247341
|
| Type of Sponsor |
Other [Dr.Sarvagya Pathak] |
|
|
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 Sarvagya Pathak |
Kunwar Shekhar Vijendra Ayurved Hospital and Research Centre |
OPD No-3, Department Shalyatantra, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Adarsh Institutional Area, Babu Vijendra Marg, Shobhit Univeesity,Gangoh,Sharanpur,UP-247341
Saharanpur
UTTAR PRADESH |
8310440564
sarvagyapathak123@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 |
Unspecified Pilonidal Sinus |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RASANJANADI LEPA, Reference: CHAKRADUTTA P.N-19, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | POVIDONE IODINE SOLUTION | Stan j Monterey et.al Evaluation of the role of povidone iodine in the prevention of surgical site infection , Surgery open science . |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group of patient 16 to 45 years.
Patient diagnosed with Pilonidal Sinus & Abscess as per diagnostic criteria .
Patient capable of reading , completing, and assigning the consent from participating in the study. |
|
| ExclusionCriteria |
| Details |
Presenting with dry & hard ulcer
Presenting with Vatadhik Lakshan
pregnant and lactating women
Addiction to drugs and alcohol
Abnormal bleeding from the wound using drugs that affect wound healing such as corticosteroids
Using antibiotics prior to surgical intervention
Not continuing the proposed treatment until the end of the study or request to leave the study
History of severe allergy or anaphylactic shock caused by similar treatment
Patient who has undergone organ transpiration
Known case of connective tissue disease
Known allergies to herbal drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in other symptoms or Pilonidal Sinus
Wound dimension
Depth of wound
Wound excaudate quantity
Bacterial load by culture & sensitivity test
CRP
Time period
Wound volumetry
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other symptoms like pain |
After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.
Partially improvement after 7 days-patient get 40-60 percent relief from sign and symptoms.
Improvement after 14 days- patient get 60-80percent relief from sign and symptoms.
cured after 21 days -patient get 80-100 percent relief from sign and symptoms . |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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)
|
24/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is Randomised ,Parallel group, active controlled trial to evaluate the safety and efficacy of Rasanjanadi lepa, in 172 patient aged between 16 to 45 years , over a period of 18 months. The patient will be of 21 days . During the trial assessment will be done on 0th , 7th, 14th, 21th, 28th days . After trial , follow up will be done after 43rd , 58th, 73rd, & 88th day after cessation of procedure. |