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CTRI Number  CTRI/2026/02/103855 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two ayurvedic local treatments in patients after piles surgery 
Scientific Title of Study   COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF JATYADI TAILA SUPPOSITORY AND JATYADI TAILA PICHU IN MANAGEMENT OF POST OPERATIVE OPEN HEMORRHOIDECTOMY 
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 Jinal Goti 
Designation  PG Scholar 
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India 
Phone  7069782347  
Fax    
Email  jinal.goti111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr KL Mahajan 
Designation  Professor and guide  
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India 
Phone  9763443730  
Fax    
Email  drklmahajan64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr KL Mahajan 
Designation  Professor and guide  
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Department of Shalyatantra ,Parul institute of ayurved and research ,Parul University,Vadodara -391760,Gujarat
Vadodara
GUJARAT
391760
India 
Phone  9763443730  
Fax    
Email  drklmahajan64@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Jinal Goti 
Address  Post graduate scholar, Department of Shalyatantra, Parul institute of ayurved and research, Parul University, Vadodara, Gujarat -391760, India 
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 Jinal Goti  Khemdas Hospital  OPD no.2, Ground floor, Parul Institute of Ayurved and Research, Parul University, Vadodara - 391760, Gujarat. Vadodara GUJARAT
Vadodara
GUJARAT 		 07069782347

jinal.goti111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE IEC-PIAR HR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: jatyadi taila suppository, Reference: Sharangdhar samhita madhyam khand 9/168-171,, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: jatyadi taila pichu, Reference: Sharangdhar samhita madhyam khand 7/1-4, Route: Rectal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing open hemorrhoidectomy surgery
2.Age between 18 to 60 years
3.Willing to provide written informed consent
 
 
ExclusionCriteria 
Details  1.Known allergy to Jatyadi Taila ingredients
2.Pregnant or lactating women
3.Patients with malignancy active TB or chronic diarrhea
4.Post operative infection.
5.Severe systemic illness or immune compromised state  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes of the study include assessment of post-operative pain using the Visual Analogue Scale (VAS 0–10), evaluation of wound healing based on granulation tissue formation using standardized grading, and assessment of burning sensation using a graded subjective scale. These parameters will be evaluated at baseline Day 0, Day 7, and Day 14.  • All patients will be observed for 14 days during the treatment period and further followed up on Day 15 and Day 30.
• Clinical parameters will be recorded on Day 0, Day 7, and Day 14 using scoring systems. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   28/02/2026 
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="1"
Months="6"
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 - NO
Brief Summary  
This study is a randomized, open-label, comparative clinical trial designed to evaluate the efficacy of Jatyadi Taila suppository and Jatyadi Taila Pichu in the management of post-operative wounds following open hemorrhoidectomy. Fifty patients undergoing open hemorrhoidectomy will be randomly allocated into two groups: Group A will receive Jatyadi Taila suppository per rectum once daily, and Group B will receive Jatyadi Taila Pichu application once daily, for a duration of 14 days. The primary outcomes include assessment of post-operative pain using the Visual Analogue Scale, wound healing based on granulation tissue formation, and burning sensation. Secondary outcomes include discomfort during defecation, time required for complete wound healing, patient satisfaction, need for rescue medication, and safety assessment. Clinical evaluations will be carried out at baseline, Day 7, Day 14, with follow-up on Day 15 and Day 30. The study aims to compare the effectiveness, safety, and patient acceptability of these two Ayurvedic treatment modalities and to determine whether the suppository form offers advantages over the traditional Pichu method in post-operative hemorrhoidectomy care.

 
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