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CTRI Number  CTRI/2025/03/081545 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical study on unsatisfactory bowel using Ayurvedic medicine 
Scientific Title of Study   The Effect of Tri-Arm Ayurvedic Intervention on Functional Constipation - A Randomized Clinical Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indrodiya Hemaxi 
Designation  Ph.D. Scholar 
Affiliation   
Address  Department of Kayachikitsa, G.J. Patel Institute of Ayurvedic Studies and Research centre,New Vallabh vidhyanagar, Anand, Gujarat

Anand
GUJARAT
388121
India 
Phone  9624038100  
Fax    
Email  indrodiyah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Manchak Kendre  
Designation  Professor and Head of Department 
Affiliation  G.J. Patel Institute of Ayurvedic Studies and Research centre 
Address  Department of Kayachikitsa,G.J. Patel Institute of Ayurvedic Studies and Research centre ,New Vallabh vidhyanagar, Anand, Gujarat

Anand
GUJARAT
388121
India 
Phone  9429200112  
Fax    
Email  manchak.kendre@cvmu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Hemaxi Indrodiya  
Designation  Ph.D. Scholar 
Affiliation  G.J. Patel Institute of Ayurvedic Studies and Research centre 
Address  Department of Kayachikitsa,G.J. Patel Institute of Ayurvedic Studies and Research centre,New Vallabh vidhyanagar, Anand, Gujarat

Anand
GUJARAT
388121
India 
Phone  9624038100  
Fax    
Email  indrodiyah@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  GJ Patel Institute of Ayurvedic Studies and Research Center 
Address  Department of Kayachikitsa, G.J. Patel Institute of Ayurvedic Studies and Research center, New Vallabh vidhyanagar, Anand, Gujarat, PIN CODE - 388345, India 
Type of Sponsor  Private 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 
Dr Hemaxi Indrodiya  Dept of Kayachikitsa OPD Block Indian Institute of Ayurved Research and Hospital   150 ft Ring road, Kalawad Road, Ishwariya Road, Ishwariya, Rajkot Gujarat 360110
Rajkot
GUJARAT 
9624038100

indrodiyah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL (HUMAN) 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: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trikatvadi Varti, Reference: Chakradatta, Udavarta Chikitsa Prakarana , Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 3 Weeks, Reference: No, Route: -, Dosage Form: Varti/ Suppository, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Trivruta churna, Reference: Charaka samhita Kalpa sthana 7 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 3 Weeks, Reference: Yes, Route: warm water, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Bindu Ghrita , Reference: Sharangdhara samhita, Madhyama Khanda, Route: Topical, Dosage Form: Ghrita, Dose: 1(drops), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 3 Weeks, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Study participants of both genders and age group 30 to 60 years with Functional constipation defined according to the Rome IV criteria and able to understand the procedure, will be eligible for inclusion in the study.
Patients suffering from functional constipation and eligible for inclusion in the study will be advised to refer to protocol details.
Patients ready to stop taking the previous medications for constipation.
Their voluntary participation will be confirmed by signing the informed consent. The objectives, potential benefits and risks of the research will be explained to them.
 
 
ExclusionCriteria 
Details  Patients suffering from secondary constipation
Patients with a diagnosis or history of obstructive ileus
Suspected/confirmed diagnosis of irritable colon syndrome, ulcerative colitis, Crohn’s disease or malignant digestive tract disease
Taking opioid analgesic and antidepressants
Pregnant and lactating women
Known cases of uncontrolled Diabetes mellitus, HIV, TB, Thyroid disorders etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the symptoms of functional constipation (Rome IV Criteria)  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Patients Assessment of Constipation-Quality of life (PAC-QOL)questionnaire   21 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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/ Phase 3 
Date of First Enrollment (India)   04/03/2025 
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="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  

Functional constipation is a prevalent chronic condition among older individuals. The pathophysiology of functional constipation is multifactorial and includes diet, colonic motility as well as absorption, anorectal motor and sensory function, and behavioral as well as psychological factors. It negatively impacts health-related quality of life and economic burdens. After ample research, still patients are dissatisfied with their symptom improvement, adverse effects, and inconvenience. This study of local treatment will help to minimize the dissatisfaction of the patient with present therapies. In the present study, a total of 120 (40 in each group) incidentally enrolled patients with Functional constipation diagnosed with Rome IV criteria will be allotted to any one group among three with a computerized randomization method. This randomized clinical trial aimed to evaluate the efficacy of Bindu ghrita local application on the umbilicus, Trikatvadi varti per rectal administration, and Trivritta churna orally on functional constipation. Patients will be treated for 3 weeks, in the first week with daily medicine, in the second week with alternate-day medicine, and in the third week without medicine in follow-up. Patients who have more than 3 motions/day will be excluded from the study. Patients having constipation for more than 3 days with medicine will be excluded from the study and will be given rescue medicine. Assessment will be done with Rome IV criteria and the question of PAC-QOL. At the end of the trial, data will be collected and subjected to appropriate statistical analysis, and a final conclusion will be framed.

 
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