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CTRI Number  CTRI/2025/04/084678 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 07/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Management of Chronic Anal Fissure through Ayurveda and Yoga. 
Scientific Title of Study   Efficacy and safety of Jatyadi Ghrita and Ashwini Mudra in Chronic Anal Fissure: An open-label prospective randomized controlled pilot study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajit Kumar Pradhan 
Designation  Medical Officer AYUSH Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH All India Institute of Medical Sciences Bhubaneswar Odisha Pin- 751019

Khordha
ORISSA
751019
India 
Phone  9337832305  
Fax    
Email  ayush_ajit@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Ajit Kumar Pradhan 
Designation  Medical Officer AYUSH Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH All India Institute of Medical Sciences Bhubaneswar Odisha Pin- 751019

Khordha
ORISSA
751019
India 
Phone  9337832305  
Fax    
Email  ayush_ajit@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Ajit Kumar Pradhan 
Designation  Medical Officer AYUSH Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH All India Institute of Medical Sciences Bhubaneswar Odisha Pin- 751019

Khordha
ORISSA
751019
India 
Phone  9337832305  
Fax    
Email  ayush_ajit@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Research Section All India Institute of Medical Sciences Bhubaneswar At: Sijua Po: Dumuduma Dist: Khurdha Odisha Pin: 751019 India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  Sijua, Patrapada PO: Dumuduma Pin: 751019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Ajit Kumar Pradhan  Room No 3, Department of AYUSH All India Institute Of Medical Sciences, Bhubaneswar  At: Sijua, PO: Dumuduma Dist: Khordha Odisha Pin: 751019 India
Khordha
ORISSA 		 9337832305

ayush_ajit@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jatyadi Ghrita, Reference: Astanga Ayurveda, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Apply only on affected area only
2Comparator ArmDrugClassical(1) Medicine Name: Jatyadi Ghrita with Ashwini Mudra, Reference: Astanga Hridaya and Gheranda Samhita, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Aswinimudra is an Yogic procedure
3Comparator Arm (Non Ayurveda)-Nifedipine 0.3% and Lignocaine 1.5% creamPatients enrolled in group c will be treated with topical nifedipine 0.3% and lidocaine 1.5% cream twice daily for 8 weeks.
Intervention  Topical application of Jatyadi Ghrita  Jatyadi Ghrita is a polyherbal Ayurvedic formulation. Patients in group A will be treated with topical Jatyadi Ghrita ointment twice daily for 8 weeks.  
Intervention  Topical Application of Jatyadi Ghrita and Ashwini Mudra.  Ashwini Mudra is a Yogic practice. Patients enrolled in group B will be treated with topical Jatyadi Ghrita ointment with the practice of Ashwini Mudra twice daily for 8 weeks.  
Comparator Agent  Topical Nifedipine 0.3% with Lidocaine 1.5% cream  Patients enrolled in group C will be treated with topical application of Nifedipine 0.3% with Lidocaine 1.5% cream 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Willing to participate.
2. The age should be 16 to 60 years
3. Gender will be both male and female
4. Patients with a diagnosis of chronic anal fissure who had symptoms for more than 6 weeks.
5. Patients whose symptoms are not resolved by stool softeners, high fiber diet, warm sitz bath, etc.
6. A physical examination will show an anal ulcer with indurated edges and/or skin tag.
7. The VAS score should be between 3 to 7.
 
 
ExclusionCriteria 
Details  1. History of reaction to topical agents.
2. Patients whose symptoms resolved within 6 weeks by stool softeners, high fiber diet, and warm sitz bath.
3. Patient with multiple anal fissures.
4. Patients suffering from severe anemia, carcinoma, chrons disease, ulcerative colitis, diabetes mellitus, hypertension, and HIV.
5. Pregnant women
6. Tuberculous ulcers and leukemic ulcers should be excluded.
7. Patient with perianal abscess, anal fistula, and third and fourth-degree hemorrhoids.
8. Chronic anal fissure patients with severe pain (VAS more than 7) and excessive bleeding per anum should be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatment  Baseline, 2 weeks, 4 weeks and 8 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Healing period of chronic anal fissure.
Adverse events during treatment.
 		 Baseline, 2 weeks, 4 weeks and 8 weeks of treatment. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   10/06/2025 
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="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 - NO
Brief Summary  

This is an open label prospective randomized controlled trial approved by Institutional Ethical Committee, All India Institute of Medical Sciences, Bhubaneswar. The primary objective of the study is to establish the effectiveness and safety of topical Jatyadi Ghrita and Ashwini Mudra practice in chronic anal fissures.  All the eligible patients based on inclusion and exclusion criteria will be enrolled after taking of written consent. Total 66 patients will be divided into three groups and treated with topical Jatyadi Ghrita ointment, topical Jatyadi Ghrita ointment with the practice of Ashwini Mudra and topical nifedipine 0.3% and lidocaine 1.5% cream twice daily for 8 weeks for three separate groups. The primary outcomes will be change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatment.

 
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