| CTRI Number |
CTRI/2025/03/083200 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of bhunimbadi churna with gudambu in the management of grahani roga w.s.r to irritable bowel syndrome. |
|
Scientific Title of Study
|
A randomized clinical study to evaluate the efficacy of bhunimbadi churna with gudambu in the management of grahani roga w.s.r 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 |
Virendra Singh |
| Designation |
Ph.D Scholar & Associate professor |
| Affiliation |
Keshav ayurved medical college and hospital aklera jhalawar rajasthan |
| Address |
Room no. B-1, Departmental block, keshav ayurved medical college NH-52 jhalawar road aklera Rajasthan
Jhalawar
RAJASTHAN
326033
India |
| Phone |
09413720487 |
| Fax |
|
| Email |
drvirendrabishno@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indumati sharma |
| Designation |
Associate professor Kayachikitsa |
| Affiliation |
M.M.M. Govt Ayurvedic college udaipur |
| Address |
Room no.1 Kayachikitsa OPD College attached hospital of Madan Mohan Malviya Govt. ayurvedic college Udaipur
Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Virendra Singh |
| Designation |
Ph.D Scholar and Associate professor |
| Affiliation |
Keshav ayurved medical college and hospital aklera jhalawar rajasthan |
| Address |
OPD chamber no 1, Keshav ayurved medical college NH-52 Jhalawar road Aklera Jhalawar Rajasthan
Jhalawar
RAJASTHAN
326033
India |
| Phone |
09413720487 |
| Fax |
|
| Email |
drvirendrabishno@gmail.com |
|
|
Source of Monetary or Material Support
|
| keshav ayurved medical college and hospital, aklera, district- jhalawar state-Rajasthan, india.
pin code-326033
njssaklera@gmail.com, keshavayumc@gmail.com |
|
|
Primary Sponsor
|
| Name |
keshav ayurved medical college and hospital aklera jhalawar Rajasthan |
| Address |
keshav ayurved medical college and hospital, aklera, district- jhalawar state-Rajasthan, india.
pin code-326033
njssaklera@gmail.com, keshavayumc@gmail.com |
| Type of Sponsor |
Private 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 Virendra Singh |
Keshav ayurved medical college & hospital aklera jhalawar |
ROOM NO.1 College attached hospital of Keshav ayurved medical college & hospital aklera, near bus stand aklera,district- jhalawar state-Rajasthan, india.
pin code-326033
njssaklera@gmail.com keshavayumc@gmail.com
Jhalawar
RAJASTHAN |
9413720487
drvirendrabishno@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee M.M.M. Govt.Ayurved College udaipur |
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: Bhunimbadi churna, Reference: (Chakradatta –Grahani chikitsa 19-20, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -GUDAMBU), Additional Information: Gurambu (anupan) prepration ratio-
Gur (Jaggery) 1 Part with Shuddh Jal (pure water) 1 Part | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: PLACEBO, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -PLACEBO ORAL MEDICINE
(BARLEY FLOUR CHURNA) |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to sign the consent form for trial.
2.The patients aged between 16 to 70 years will be selected.
3.The patients having clinical signs and symptoms of Grahani and I.B.S. as per Rome 3rd criteria. |
|
| ExclusionCriteria |
| Details |
1.Mixed infection with parasites like round worms, hook worms etc.
2.Patients with bleeding per Rectum.
3.Patients with evidence of malignancy.
4.Patients having concomitant illness like HTN, DM, Amoebic dysentery,Ulcerative colitis, Malabsorption syndrome, Inflammatory Bowel Diseases and Intestinal tuberculosis, Lactase deficiency diarrhoea.
5.Patients suffering from major systemic illness with corticosteroids, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
6.Alcoholics and drug abusers.
7.Pregnant or lactating women.
8.Patients who have completed participation in any other clinical trial during the past six months.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the clinical symptoms of ‘Grahani Roga’ (Ch chi 15/53)-
1) Atisarusht or vibaddham drava mala (Diarrhoea or Constipation )
2) Trishna ( excess thirst)
3) Arochak (anorexia)
4) praseka (excessive salivation)
5) Lohaamgandhistiktamla udgarshch (belching eructation having metabolic smell, smell of ama and bitter and sour tastes. |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in the objective parameters.
2. Change in Hamilton Depression Rating Scale. |
2 WEEKS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/04/2025 |
| 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="0"
Months="6"
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
|
The primary purpose of this protocol is to evaluate the efficacy of Bhunimbadi Churna with Gurambu in the management of Grahani Roga (Irritable Bowel Syndrome). The study aims to assess whether this Ayurvedic formulation can provide significant relief in GRAHANI Roga w.s.r. To IBS symptoms, improve digestive health, and enhance the quality of life for affected individuals |