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CTRI Number  CTRI/2026/01/100817 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [PICHU OR LOCAL APPLICATION]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find a good alternative between two oils for faster healing of post operative fistulous wound. 
Scientific Title of Study   A Clinical Comparative Study of Nishadi Taila and Lajjalumoola Taila in the Management of Bhagandar Vrana with special reference to Post Operative Wound of Fistula in Ano 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshu Yadav 
Designation  PG Scholar , Dept. of Shalya Tantra  
Affiliation  Shri N.P.A Govt. Ayurved College , Raipur  
Address  Dept. of Shalya Tantra ,GAC Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9827979709  
Fax    
Email  drhimanshu1005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Avinash Markam 
Designation  Lecturer , Dept. of Shalya Tantra  
Affiliation  Shri N.P.A Govt. Ayurved College , Raipur  
Address  Dept. of Shalya Tantra ,GAC Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9977827911  
Fax    
Email  avi.kavi06@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Avinash Markam 
Designation  Lecturer , Dept. of Shalya Tantra  
Affiliation  Shri N.P.A Govt. Ayurved College , Raipur  
Address  Dept. of Shalya Tantra ,GAC Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9977827911  
Fax    
Email  avi.kavi06@gmail.com  
 
Source of Monetary or Material Support  
Shri Khudadad Dungaji Govt. Ayurvedic College, Raipur, C.G. Pin- 492001 
 
Primary Sponsor  
Name  Himanshu Yadav 
Address  Shri Khudadad Dungaji Govt. Ayurvedic Medical College, Raipur C.G. Pin - 492001 
Type of Sponsor  Government medical college 
 
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 
Himanshu Yadav  Shri Khudadad Dungaji Govt. Ayurvedic Hospital , Raipur  OPD no 17, Shalya Tantra Department
Raipur
CHHATTISGARH 		 09827979709

drhimanshu1005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, GAC RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: LAJJALU MULA TAILA , Reference: GADA NIGRAHA , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: NISHADI TAILA , Reference: CHAKARADUTTA , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Sign and symptoms of Bhagandar
2.External opening present
3.Post operative wound of low anal fistula ( Fistulotomy )
 
 
ExclusionCriteria 
Details  1. HIGH ANAL FISTULA
2. FISTULA HAVING MULTIPLE OPENING OR COMPLICATED FISTULA
3.ANY OTHER CONGENITAL DISEASE OF RECTUM AND ANAL CANAL
4.HIV, HEPATITIS B
5.SYSTEMIC DISEASE LIKE DM,BLEEDING DISORDER, ACTINOMYCOSIS,TUBERCULOSIS,ULCERATIVE COLLITIS , CROHNS DISEASE
6.MALIGNANCY,PREGNANCY
7.STRICTURE IN ANO
8.INCONTINENCE OF STOOL 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the comparative effect of healing in post operative wound of Fistula in Ano   8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The better yielding oil may be used for further study  8 weeks 
 
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)   16/03/2026 
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="6"
Days="15" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  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 [drhimanshu1005@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A PROPER COMPARATIVE STUDY HAS NOT BEEN DONE YET BETWEEN NISHADI TAILA  AND LAJJALU MULA TAILA ON POST OPERATIVE WOUND MANAGEMENT OF FISTULA IN ANO. SO NEED TO SEE WHICH ONE IS BETTER AND CONVINIENT AND ECONOMICAL IN TERMS OF MANAGEMENT OF POST OPERATIVE WOUND OF FISTULA IN ANO.  
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