| CTRI Number |
CTRI/2025/05/087826 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial on effect of Bilvashalatu Majja and Apakva Bilvaphala Majja in the patient suffering from irregular bowel habits (Sometime Diarrhea or constipation). |
|
Scientific Title of Study
|
Study on Bilvashalatu (Aegle marmelos Linn.) and assess its clinical efficacy in the management of Grahani roga wsr to IBS |
| 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 Sheetal Chandulal Dhamecha |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
327, Department Of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar -361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7802975791 |
| Fax |
|
| Email |
shitaldamecha791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Bhupesh R Patel |
| Designation |
Professor of Dravyaguna Department |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
329, Department Of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar -361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574590 |
| Fax |
|
| Email |
brpayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Chandulal Dhamecha |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
327, Department Of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar -361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7802975791 |
| Fax |
|
| Email |
shitaldamecha791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar-361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
329, Department of Dravyaguna, institute of teaching and research in
Ayurveda,opposite to B division police station Jamnagar -361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sheetal C Dhamecha |
Institute of Teaching and Research in Ayurveda Hospital |
OPD No A-1,
Department of Dravyaguna, Institute of Teaching and Research in Ayurveda,Jamnagar
Jamnagar 361008
Jamnagar
GUJARAT |
7802975791
shitaldamecha791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute of teaching and research in Ayurveda |
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: Kutaja Ghanavati, Reference: Ayurvedic Formulary of India Part - 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilva Shalatu Majja, Reference: Brihattrayi and Vrundamadhav, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apakva Bilvaphala Majja, Reference: Ayurvedic Pharmacopoeia of India Part 1 Vol. 1 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having cardinal symptom of Grahani roga i.e. Muhur Baddha or Drava Mala pravritti and any two of associated complain i.e. Punahapunah Malapravritti, Bhojanottar Malapravritti, Saphena-Sashabda-Sashoola Malapravritti, Arochaka, Udarashool, Katu - Tikatamlodgara will be included for the study
Patient must have more than or equal to 2 of Rome IV criteria of IBS associated with abdominal pain on average at least 1 day/week in the last 3 months will be included. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from Acute diarrhea, Intestinal T.B., Ulcerative colitis, Gastric and peptic ulcer, Crohn’s disease, any genetic and auto immune GIT disorders.
2.Patient suffering from Bleeding per rectum
3.Pregnant women and Lactating mother.
4.Uncontrolled systemic disorders like Hypertension (more than 160/100mm-Hg) and Diabetes mellitus (RBS more than 180mg/dl).
5.Known cases of Tuberculosis, HIV, VDRL, Hep. B positive, COPD etc.
6.Patients who have a history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in scoring pattern in symptoms of Grahani roga
2. IBS - Symptom Severity Scale - on 0th, 14th, 28th day. |
0th and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Agnibala assessment
2. Number of adverse events will be assessed on the basis of lab investigation.
3.Changes in Stool investigations i.e. Routine & Microscopic, Occult blood, Mucus, Indigested food particles
4.Changes in Haematological parameter i.e. CBC, ESR
5.Changes in Biochemical parameter i.e. SGPT, SGOT and Serum creatinine. |
0th and 28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
21/04/2026 |
| 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
|
This trial is randomized clinical trial to evaluate the efficacy of Bilvashalatu Majja Churna compare to Apakvabilvaphala Majja Churna along with standard control drug Kutaja Ghanavati in the management of Grahani roga wsr to IBS. Selected patients will be divided in to three group on basis of computer generated randomization. In this study first group will receive Kutajaghanavati in dosage of 2 tab (250mg each) empty stomach twice a day for 28 days. While in second and third group will receive Bilvashalatu Majja & Apakvabilvaphala Majja Churna respectively in dosage of 5 gm empty stomach twice a day for 28 days |