FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103134 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to Check the Effect of Vranropan Malahar in Healing Parikartika With Special Reference to Anal Fissure 
Scientific Title of Study   Randomized Controlled Open Labelled Clinical Study of Efficacy of Vranropan Malahar in the Management of Parikartika with Special Reference to Fissure 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  DrSadhana Subhash Dhaytadak 
Designation  Ph D Scholar  
Affiliation  Ph D scholar 
Address  Government Ayurvedic College, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  8308172831  
Fax    
Email  sadhanakendre6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Haribhau Amilkanthwar 
Designation  Associate professor 
Affiliation  Associate professor 
Address  Department of Shalya tantra, Government Ayurvedic College, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DrSadhana Subhash Dhaytadak 
Designation  Ph D Scholar  
Affiliation  Ph D Scholar  
Address  Department of Shalya tantra, Government Ayurvedic College, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  8308172831  
Fax    
Email  sadhanakendre6@gmail.com  
 
Source of Monetary or Material Support  
Shalyatantra Department Government Ayurvedic college Nanded 431601 Maharashtra , India  
 
Primary Sponsor  
Name  Government Ayurvedic college Nanded 
Address  Department of Shalyatantra, Government Ayurvedic College, Nanded 431601 Maharashtra, India  
Type of Sponsor  Research institution and hospital 
 
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 
DrSadhana Subhash Dhaytadak  Government Ayurvedic College and hospital, Nanded  Department of Shalya tantra, Government Ayurvedic College, Nanded Department of Shalya tantra, Government Ayurvedic College, Nanded
Nanded
MAHARASHTRA 		 08308172831

sadhanakendre6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Ayurvedic College Nanded  Approved 
University approved letter  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K90-K95||Other diseases of the digestive system. Ayurveda Condition: PARIKARTIKA-VIRECANAVYAPAD,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vranropan Malahar, Reference: Sushrut Sutrasthan 37, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 0 7th 15th 21st 30th day follow ups
2Comparator Arm (Non Ayurveda)-Nifedipine 2%Nifedipine 2% is Relaxes internal anal sphincter smooth muscle it decreases sphincter pressure. Route: Topical, Dosage Form:Ointment Dose: 1(NA), Frequency:QD, Bhaishajya Kal: Sabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 0 7th 15th 21st 30th day follow ups
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients clinically having diagnosed by inspection as having parikartika fissure in ano
patients of parikartika fissure in ano with systemic diseases which are well under control  
 
ExclusionCriteria 
Details  patients having Parikartika Fissure in ano secondary to Ulcerative colitis, Chrons disease Syphilis TB Ca of Rectum
Patients having uncontrolled Systemic disease
patients with infectious diseases like HIV HBsAG  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To heal or reduce the size of parikartika fissure in ano   30 days  
 
Secondary Outcome  
Outcome  TimePoints 
To reduce anal spasm  30 days 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   05/02/2026 
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="3"
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 - 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sadhanakendre6@gmail.com].

  6. For how long will this data be available start date provided 26-09-2025 and end date provided 01-01-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This Randomised controlled open labelled clinical study of  Vranropan Malahar will be applied on daily basis for 30 days or 4 weeks or till the complete healing of the ulcer is experimental group. The Nifidipine ointment will be applied on daily basis for 30 days or 4 weeks or till the complete healing of the ulcer. both will use at OPD or IPD level.  
Close