| CTRI Number |
CTRI/2026/02/104726 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison to Evaluate the Effect of Chitrakadi Vati Alone versus Chitrakadi Vati with Shunthi Ghrita in the Managing Grahani roga(Chronic Digestive Disorder) |
|
Scientific Title of Study
|
A comparative clinical study of the efficacy of Chitrakadi vati with Chitrakadi vati and Shunthi ghrita in management of Grahani roga. |
| 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 Roshani Ramesh Tambe |
| Designation |
PG Scholar |
| Affiliation |
Dr. Rajendra Gode Ayurved College Hospital and Research Centre Amravati |
| Address |
Department of Kayachikitsa Dr. Rajendra Gode Ayurved College Hospital and Research Centre University Mardi Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
8459374706 |
| Fax |
|
| Email |
roshanitambe8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Banarase |
| Designation |
PG Guide |
| Affiliation |
Dr. Rajendra Gode Ayurved College Hospital and Research Centre Amravati |
| Address |
Department of Kayachikitsa room no 1 Ground floor Dr. Rajendra Gode Ayurved College Hospital and Research Centre University Mardi Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
9096964423 |
| Fax |
|
| Email |
sachinbanarase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshani Ramesh Tambe |
| Designation |
PG Scholar |
| Affiliation |
Dr. Rajendra Gode Ayurved College Hospital and Research Centre Amravati |
| Address |
Department of Kayachikitsa Room no 1 Ground floor Dr. Rajendra Gode Ayurved College Hospital and Research Centre University Mardi Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
8459374706 |
| Fax |
|
| Email |
roshanitambe8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Gode Ayurved College Hospital And Research Centre Amravati |
|
|
Primary Sponsor
|
| Name |
Dr. Roshani Ramesh Tambe |
| Address |
Department of Kayachikitsa Dr. Rajendra Gode Ayurved College Hospital And Research Centre University Mardi Road Amravati Maharashtra India 444602 |
| Type of Sponsor |
Other [Self] |
|
|
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 Roshani Ramesh Tambe |
Dr. Rajendra Gode Ayurved College Hospital and Research Centre |
Department of Kayachikitsa Room no. 1 Ground floor Dr. Rajendra Gode Ayurved College Hospital and Research Centre University mardi road Amravati Maharashtra India 444602
Amravati
MAHARASHTRA |
8459374706
roshanitambe8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr, Rajendra Gode Ayu. college Amravati |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi vati, Reference: Bhaishajya Ratnavali grahani rogadhikar 8/26-27, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi vati, Reference: Bhaishajya ratnavali grahani rogadhikar 8/26-27, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -(2) Medicine Name: Shunthi Ghrita, Reference: Sahastrayogam 19/137, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patients of Grahani roga having cardinal signs of Grahani roga as per
classical Ayurveda texts.
2. Age group within 20-40 years.
3. Participants irrespective of gender and who give consent for the treatment will be
included. |
|
| ExclusionCriteria |
| Details |
1. Patients who received antibiotics or any active drug treatment.
2. Known cases of active PR bleed and GI disease.
3. History of colon resection, Abdominal surgery.
4. Any severe systemic disorder.
5. Immunocompromised Individuals or individuals on immunosuppressive drugs.
6. Pregnant women, lactating mothers and premenopausal women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in total clinical symptom score (including frequency of bowel movements, consistency of stool, and abdominal pain) assessed using a validated Grahani Symptom Rating Scale from baseline to day 30. |
Assessments will be conducted at baseline (Day 0), and then at weekly intervals (Day 7, 14, 21). The primary endpoint assessment for final efficacy analysis will be conducted on Day 30. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [roshanitambe8@gmail.com].
- For how long will this data be available start date provided 02-03-2026 and end date provided 02-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate and compare the therapeutic effectiveness of two Ayurvedic treatment approaches in managing Grahani Roga. Grahani Roga, described in classical Ayurvedic texts, is primarily caused by impairment of Agni (digestive fire) leading to improper digestion, malabsorption, and chronic bowel irregularities. It closely resembles Irritable Bowel Syndrome (IBS) in modern medicine. Since current conventional management mainly offers symptomatic relief with frequent recurrence, there is a need for safer and more holistic alternatives. This research is designed as an open-label, randomized comparative clinical study including 74 diagnosed patients of Grahani Roga, divided equally into two groups. Group A will receive Chitrakadi Vati. Group B will receive Chitrakadi Vati along with Shunthi Ghrita. The treatment duration is 30 days with periodic assessments on the 0th, 7th, 14th, 21st, and 30th day. Evaluation will be based on classical subjective parameters such as irregular bowel habits, anorexia, distaste, fever, and eructation, graded using a standardized scoring system. Statistical analysis will determine intra-group and inter-group significance. The study hypothesizes that the combination therapy (Chitrakadi Vati + Shunthi Ghrita) will be more efficacious than Chitrakadi Vati alone due to its enhanced Deepana, Pachana, Grahi, and Agni-balancing properties. This research aims to provide evidence-based validation of classical Ayurvedic formulations in the management of Grahani Roga and contribute to integrative gastrointestinal care. |