| CTRI Number |
CTRI/2025/02/081374 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of Shadav Churna and Bhunimbadi Churna in patient’s of Grahani Disease. |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHADAV CHURNA AND BHUNIMBADI CHURNA IN MANAGEMENT OF GRAHANI VYADHI WITH SPECIAL REFERENCE TO IRRITABLE BOWEL SYNDROME. |
| 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 Lajja Mangrola |
| Designation |
PG Scholar |
| Affiliation |
Padmashree Dr D Y Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor OPD No 1 , Department of Kayachikitsa, D Y Patil Vidyanagar , sector 7, Nerul ,Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9724678377 |
| Fax |
|
| Email |
lajja.mangrola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Satpute |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr D Y Patil School of Ayurveda,Nerul, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor OPD No 1 , Department of Kayachikitsa, D Y Patil Vidyanagar , sector 7, Nerul ,Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9890486825 |
| Fax |
|
| Email |
kalpana.satpute@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Satpute |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr D Y Patil School of Ayurveda,Nerul, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor OPD No 1 , Department of Kayachikitsa, D Y Patil Vidyanagar , sector 7, Nerul ,Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9890486825 |
| Fax |
|
| Email |
kalpana.satpute@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D Y Patil School of Ayurveda and Hospital, Nerul, Navi Mumbai . |
|
|
Primary Sponsor
|
| Name |
Dr Lajja Mangrola |
| Address |
D Y Patil School of Ayurveda, Sector 7, Nerul, Navi Mumbai - 400706 |
| 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 Lajja Mangrola |
D Y Patil School of Ayurveda |
1st floor, OPD No 1 , Department of Kayachikitsa,
D Y Patil School of Ayurveda, D Y Patil University, Sector 7, Nerul, Navi Mumbai- 400706
Thane
MAHARASHTRA |
9724678377
lajja.mangrola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC D Y Patil Deemed to be University, School of Ayurveda , Nerul , Navi Mumbai. |
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 | Drug | Classical | | (1) Medicine Name: Shadav Churna , Reference: Gadnigrah - Prayog Khand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Madhyabhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: ( To be given in Saman kaal) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhunimbadi Churna, Reference: Ch. Chikitsa 15 / Grahanidoshachikitsaadhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Madhyabhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshna Jala ), Additional Information: ( To be given in Samankaal ) |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients fulfilling the subjective criteria of Grahani . Muhur/ Muhur Drava mala pravritti, Udgar, arochaka, balakshaya.
Known case of Grahani / IBS.
Diagnosis as per ROME IV Criteria for IBS.
Patients inclusive of all sex. |
|
| ExclusionCriteria |
| Details |
Known case of Active PR Bleeding & GI disease such as Crohn’s disease, Amebiasis, Celiac Disease.
History of colon resection.
Patient suffering from acute diarrhoea, Intestinal tuberculosis, Gastric and Peptic ulcer, Colitis associated with significant complications like haemorrhage, perforation, stricture, colonic cancer, toxic mega colon.
Immunocompromised individuals on immunosuppressive drugs.
Pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Grahani vyadhi |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Agni Parikshan of patients before and after the treatment. |
28 days |
|
|
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)
|
07/03/2025 |
| 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="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
|
Introduction:Grahani dosha described in classical text books of Ayurveda represents a group of disorders of digestive system caused by impairment of Agni. The cardinal features of Grahani dosha explained in the classical text books of Ayurveda, have at most similarities with the clinical features of Irritable Bowel Syndrome (IBS) as described in contemporary medicine.This is one of the common clinical problems among patients attending gastroenterology clinics. The main clinical features of this ailment are abdominal pain associated with an altered bowel habit (may present with diarrhoea or constipation or intermittently both) in the absence of any structural pathology.
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Shadav Churna and Bhunimbadi Churna in the Management of Grahani with Special Reference to Irritable Bowel Syndrome will be conducted as a randomized comparative clinical trial. A total of 60 participants will be enrolled and randomly divided into two groups: Group A (Trial Group) and Group B (Control Group), with 30 participants in each group. Group A will receive Shadav Churna, while Group B will be administered Bhunimbadi Churna. Both groups will receive a dose of 4 grams thrice daily (TDS) with Koshna Jala (warm water) as an Anupana . The route of administration will be oral, and the total duration of the treatment will be 28 days. The primary objective of this research will be to evaluate and compare the efficacy of Shadav Churna and Bhunimbadi Churna in the management of Grahani (Irritable Bowel Syndrome), thereby contributing to the scientific validation of these Ayurvedic formulations.
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