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CTRI Number  CTRI/2021/11/038017 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On: 16/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study held to see the effect of local application of Karanja patra malahara with Shatadhauta ghrita in the management of Fissure in ano. 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Karanja patra malahara(ointment) with Shatadhauta ghrita in the management of Parikartika(Fissure-in-ano) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sithara R V 
Designation  PG Scholar Shalya Tantra 
Affiliation  Dr. D.Y. Patil College Of Ayurved And Research Centre 
Address  Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7012086457  
Fax    
Email  sitharadmedico@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay C Babar 
Designation  Professor and HOD 
Affiliation  Dr. D.Y. Patil College Of Ayurved And Research Centre 
Address  Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sithara R V 
Designation  PG Scholar Shalya Tantra 
Affiliation  Dr. D.Y. Patil College Of Ayurved And Research Centre 
Address  Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7012086457  
Fax    
Email  sitharadmedico@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune 411018 Maharashtra 
 
Primary Sponsor  
Name  Sithara R V 
Address  Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune 411018 
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 
Sithara R V  Dr. D.Y. Patil College Of Ayurved And Research Centre, Pimpri, Pune  OPD NO:3, Shalya Tantra OPD, Ground floor, Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 7012086457

sitharadmedico@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Karanja patra malahara, Reference: Bhavaprakasha nighantu, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Shatadhauta ghrita, Reference: Charaka Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having classical features of Fissure-in-ano namely presence of longitudinal ulcer in the anal region (major criteria), excruciating pain during and after defecation, bleeding per rectum, constipation, burning sensation(minor criteria). Patient’s fulfilling the major criteria and atleast 3 of above minor criteria.
2) Between the age group of 18 to 60yrs will be included in the study.

 
 
ExclusionCriteria 
Details  1) Patients with K/C/O Diabetes mellitus, Hypertension under medication.
2) Patients who needs surgical intervention.
3) Patients with anemia, Crohn’s disease and ulcerative colitis.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of ayurvedic formulation in fissure in ano   15 days study with 3 followups(5,10,15) 
 
Secondary Outcome  
Outcome  TimePoints 
To study about the adverse effect if any of karanja patra malahara.  15 days study with 3 followups(5,10,15) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/02/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim of the study to see the effectiveness of ayurvedic formulation in the management of Parikartika (fissure in ano). The study will be conducted with 40 patients showing signs and symptoms of parikartika, they will be administered with ayurvedic formulation malahara twice a day for a duration of 15 days and follow up will be done on 5,10, 15 days and final conclusion will be drawn on the basis of proper statistical methods. 
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