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CTRI Number  CTRI/2025/10/095599 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Local Application]  
Study Design  Other 
Public Title of Study   Fast recovery after Nadi vrana (Pilonidal sinus) Operation using Ayurvedic Herbal Application  
Scientific Title of Study   Clinical study of Madhu- Ghrita mishrita Tilkalka lepa in post operated cases of Nadi Vrana W.S.R. to 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 Alok Kumar 
Designation  MS PG Scholar SHALYA TANTRA 
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9451110139  
Fax    
Email  alokbhu2194@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arjun 
Designation  Associate Professor  
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  6360340886  
Fax    
Email  drarjunanil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arjun 
Designation  Associate Professor  
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  6360340886  
Fax    
Email  drarjunanil@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Alok Kumar 
Address  OPD no.05 Department of Shalya Tantra Vaidya Ygya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Kumar  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalay   OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh
Bulandshahar
UTTAR PRADESH 		 09451110139

alokbhu2194@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalay Khurja Buulandshar Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: NADIVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Madhu Ghrita mishrita Tilkalka , Reference: Sushruta Samhita Vol.1 Chikitsa Sthan Visarpanadistan aroga chikitsa 17/26, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to undergo trial and give informed written consent.
Patients of either sex above 20 years and below 60 years of age.
Excised cases of Pilonidal Sinus (Nadi Vrana).
Excised cases of Pilonidal sinus with a maximum length of 5 cm. 
 
ExclusionCriteria 
Details  Patients of age below 20 years and above 60 years.
Patients having multiple sinus track .
Pilonidal sinus more than 5 cm in length.
Patients suffering from Systemic disease like Diabetese Mellitus. , Hypertension ,T.B. ,Malignancy .
HIV,HCV,HBsAg positive subjects.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in pain and tenderness of Pilonidal Sinus (Nadi Vrana)  1 Month
The trial drug will be given for 1 month and follow up will be done after 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in pain tenderness and Discharge of Nadi Vrana (Pilonidal Sinus)  After analyzing all the parameters the result will be assessed on the basis of symptomatic relief and improvement
Partial improvement after 7 days patient get 30 percent relief from sign and symptoms .improvements after 14 days patient get 45-50 percent relief from sign and symptoms Improvement after21 days patientget 60-80 percent relief from sign and symptoms
Cured after 1 month patient get 80-100 percent relief from sign and symptoms. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [alokbhu2194@gmail.com].

  6. For how long will this data be available start date provided 05-08-2025 and end date provided 02-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Shalyajanya Nadi vrana can be correlated with pilonidal sinus in the modern concept . pilonidal sinus is an epithelium lined tract .situated short distance behind the anus . in the sacrococcygeal area natal cleft containing hairs and unhealthy granulated tissue .It is due to penetration of hairs through the skin into subcutaneous tissue Itcauses recurrencet infection abscess formatin which bursts open forming recurrent sinus with pain discharge and discomfort .The several methods to treat pilonidal sinus such as wide excision bascom cleft lift technique various types of flaps However post operative recurrence following surgery is high leading to frequent and time consuming wound care .
Local application of Madhu Ghrita mishrita Tilkalka lepa helps in shodhan and ropan of the vrana .So in this research work an attemptis made to evaluate the efficacy of Madhu Ghrita mishrita Tilkalka lepa  application is better for healing in post operated cases of Nadi Vrana .
 
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