| CTRI Number |
CTRI/2026/01/102526 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Yavagu] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of Two Ayurvedic Treatments for Improving Digestive Health in People with Irritable Bowel Syndrome |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Panchkola Siddha Yavagu and
Panchamrita Parpati in the management of Grahani with special reference
to Irritable Bowel Syndrome - A Randomised Controlled 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 |
Gunjan Mehra |
| Designation |
MD Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Khera Dabar,Najafgarah, New Delhi -110073
hospital block , dpartment of swasthvritta and yoga, OPD No. 20 Khera Dabar,Najafgarh, New Delhi
hospital block , dpartment of swasthvritta and yoga, OPD No. 20 110073
South West DELHI 110073 India |
| Phone |
8700189619 |
| Fax |
|
| Email |
drgunjan28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. (Dr) Rakesh Kumar Verma |
| Designation |
Professor |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
khera Dabar, Najafgarh, New Delhi -110073
hospital block, department of Swasthvritta and yoga, OPD No. 20
South West DELHI 110043 India |
| Phone |
9990149662 |
| Fax |
|
| Email |
rakeshverma2399@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gunjan Mehra |
| Designation |
MD Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
khera Dabar, Najafgarh, New Delhi -110073
hospital block, department of Swasthvritta and yoga, OPD No. 20
South West DELHI 110043 India |
| Phone |
8700189619 |
| Fax |
|
| Email |
drgunjan28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,New Delhi -110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar, New Delhi -110073 |
| 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 Gunjan Mehra |
Ch Brahm Prakash Ayurved Charak Sansthan |
room no. 222, PG Department of Swasthvritta and Yoga,Institute Block,CBPACS Khera Dabar,Najafgarh, South WEST Delhi-110073 South West DELHI |
8700189619
drgunjan28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: nil, Ritucarya: nil, Acara Rasayana:nil, Other:pathya kalpana, Pathya/Apathya:yes, Pathya:Panchkol Siddha Yavagu, Apathya:nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchamrita Parpati, Reference: Bhaishajya Ratnavali Grahani roga Chikitsaadhyaya, Route: Oral, Dosage Form: Parpati, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -goghrita/honey), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling ROME IV criteria
2.Patient should be selected irrespective of gender and religion.
3.Patient having 3 or 4 symptoms according to aacharya charak
|
|
| ExclusionCriteria |
| Details |
1)Patients with systemic diseases Systemic disease
2)Pregnant and lactating mothers
3)Patients undergoing any drug therapy.
4)Patient with severe Comorbidities.
5)Patients with Obstructive pathology.
6)Colon and Rectal CA.
7) Patients with bleeding per rectum, ulcerative collitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Panchkola Siddha Yavagu is effective in managing Grahani.
2.Panchkola Siddha yavagu can be used as a medicated diet in patients of Grahani.
|
1. 5 weeks
2. 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0" Months="1" Days="15" |
|
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 study compares two ayurvedic treatments to see which works better for long - term digestive problems similar to irritable bowel syndrom (IBS) known in ayurveda as Grahani. One treatment is a medicated rice porridge ( panchkola siddha yavagu) and the other is a classical ayurvedic medicine (panchamrita parpati). Patients are randomly given one of the treatents, and improvement in digestion, bowel habits and abdominal discomfort is observed. The aim is to identity a safe and effective natural treatment for chronic digestive disorders |