| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: | | 2 | Comparator Arm | Drug | Classical | | (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: | | 3 | Intervention Arm | Drug | Classical | | (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. |