| CTRI Number |
CTRI/2026/03/106062 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the effect of Ayurveda dietary intervention in relieving constipation among adults |
|
Scientific Title of Study
|
An exploratory study to evaluate the effect of bhedaniya yavagu in the management of vibandha constipation |
| 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 Khushboo Kumawat |
| Designation |
MD Scholar |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
ROOM 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Dr Sarvepalii radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9928440294 |
| Fax |
|
| Email |
khushbookumawatk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Agrawal |
| Designation |
Associate Professor |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
ROOM 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Dr Sarvepalii radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9972143436 |
| Fax |
|
| Email |
drsaurabh101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Agrawal |
| Designation |
Associate Professor |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
ROOM 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Dr Sarvepalii radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9972143436 |
| Fax |
|
| Email |
drsaurabh101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurveda Dr Sarvepalli radhakrishnan rajasthan Ayurved University Jodhpur 342037 india |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurveda DSRRAU Jodhpur |
| Address |
ROOM 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Dr Sarvepalii radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Jodhpur
RAJASTHAN |
| Type of Sponsor |
Government 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 Khushboo Kumawat |
Post Graduate Institute of ayurveda DSRRAU Jodhpur |
PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Dr Sarvepalii radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Jodhpur
Jodhpur
RAJASTHAN |
9928440294
khushbookumawatk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIA DSRRAU JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhedaniya yavagu, Reference: charaka sutrasthana 2/29, Route: Oral, Dosage Form: , Dose: 200(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: NA, Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age18–70years
Patient fulfilling diagnostic criteria (ROMEIV ANNEXURE1)
Presence of Symptoms (two or more from ROMEIV) for 12 weeks or more with an onset at least 6 months prior to diagnosis
Able to give written informed consent and complete study diary/questionnaires (bowel diary)
|
|
| ExclusionCriteria |
| Details |
Known case of structural abnormalities of gastroIntestinal tract bleeding disorders ulcerative colitis Crohn s disease
Participation in another interventional clinical trial within the last 30 days
Pregnant and lactating women
Known case with a history of abdominal or anorectal surgery in the past 6 months
Known hypersensitivity or allergy to any component of Bhedaniya Yavagu or its formulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Bhedaniya Yavagu in the management of Vibandha(constipation) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish safe and cost-effective AharaKalpana for the management of Vibandha
To develop SOP for the preparation of BhedaniyaYavagu
To testthefinalpreparedrecipeonhedonicscaleanddraftasensoryanalysisreport
To explore the scope for formulating a ready to eat Bhedaniya Yavagu recipe
|
45 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/04/2026 |
| 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="0"
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
|
1 No of patients 100
2 Age of patients 18 to 70 years
3 Name of drug Bhedaniya yavagu
4 Duration of trial 45 days
5 Route Oral
6 Type of study single arm open label study
7 Follow up after 7 days 15 days 30th day |