| CTRI Number |
CTRI/2025/12/098485 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Pharmaceutical and clinical efficacy of two different form of Rodhrasava in diagnosed case of IBS Patients. |
|
Scientific Title of Study
|
A Comparative Pharmaceutical and Clinical Evaluation of Rodhrasava Prepared by two Different Methods with Special Reference to Grahani. |
| 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 Ashish Baranwal |
| Designation |
M.D Scholar |
| Affiliation |
Department of Rasa Shastra and Bhaishajya Kalpana |
| Address |
Government PG Ayurvedic College And Hospital,
Department Of Rasa Shashtra And Bhaishajya Kalpana ,Varanasi
Uttar pradesh-221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9594335001 |
| Fax |
|
| Email |
ashish.berni111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjay Kumar Pandey |
| Designation |
Professor and Head of Department of Rasa Shashtra And Bhaishajya Kalpana |
| Affiliation |
Department of Rasa Shashtra And Bhaishajya Kalpana |
| Address |
Government PG Ayurvedic College And Hospital,
Department Of Rasa Shashtra And Bhaishajya Kalpana ,Opd no. 5
Varanasi
Uttar pradesh-221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9417077401 |
| Fax |
|
| Email |
dr.spandey2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitin Sharma |
| Designation |
Assistant Professor of Department of Kaya Chikitsa |
| Affiliation |
Department of Kaya Chikitsa |
| Address |
Government PG Ayurvedic College And Hospital
Department of Kaya Chikitsa
Opd no. 8,Opd no. 11,
Varanasi,
Uttar pradesh-221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9557275726 |
| Fax |
|
| Email |
drnitinsharma7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurvedic College And Hospital Chaukaghat Varanasi-221002
Uttarpradesh
India
|
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College And Hospital Chaukaghat Varanasi |
| Address |
Government PG Ayurvedic College And Hospital Chaukaghat Varanasi-221002
Uttarpradesh
India
|
| 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 Ashish Baranwal |
Government PG Ayurvedic College And Hospital Chaukaghat Varanasi |
Department of Rasa Shastra and Bhaishajya Kalpana Opd 5.
Department Of Kaya Chikitsa
Opd 8 And Opd 11.
Varanasi
UTTAR PRADESH |
9594335001
ashish.berni111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government PG Ayurvedic College and Hospital Chaukaghat Varanasi |
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 | Other than Classical | | (1) Medicine Name: RODHRASAVA (ASAVA METHOD), Reference: NA, Route: Oral, Dosage Form: Asava, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -this formulation is prepared by Asava Method | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RODHRASAVA (ARISHTA METHOD), Reference: ASHTANG HRIDAY CHIKITSA STHAN (12/25-28), Route: Oral, Dosage Form: Arishta, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: this formulation prepared by Arishta method (Kwath fermentation) |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Grahani i.c. Muhurbaddha, Muhurshithila Mala Pravritti, Udarashula, Balakshaya, Avipaka were selected for the study. Patients fulfilling diagnostic criteria of Grahani between 20 to 60 years of age and of either sex, Patients having history of Six months or More than Six Months of Origin.
|
|
| ExclusionCriteria |
| Details |
Infestations And Infectious Diseases, Congenital Anomalies, Hereditary Diseases Known Alternative Gastrointestinal Diagnosis
Any Condition Requiring a Legal Guardian, Current or Past History of Psychotic Disorder
Type 1 and Type Diabetic Mellitus-patients Narcotic, Anti-Anxiety Medications. Any Skin Disease
Insomnia Medications
Major Cardiovascular Events in The Last 6 Months
Use Of any other Anti-IBS Drugs Within 30 Days
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Grahani Lakshans
(muhurbaddha muhurshithila malpravritti Etc.) |
07 days, 14 days, 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight gain, Bala Vriddhi, loss of laziness, proper digestion, Increase in Hunger and Passing of semisolid stools. |
14 days, 21 days, 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 2 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="2"
Months="1"
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 - NO
|
|
Brief Summary
|
This Study is interventional study trial comparing the efficacy of Rodhrasava prepared by two different methods (Asava and Arishta method) in Grahani patients. The Patients will be Randomly selected from Opd of Department of Rasa shastra and Bhaishajya Kalpana and Kayachikitsa at Government P.G. Ayurvedic College And Hospital ,Varanasi.
60 patients will be studied under 2 groups having 30 patients in each group.
Group A - 30 patients will be treated by Rodhrasava (arishta method) Group B - 30 patients will be treated by Rodhrasava (Asava method)
The follow up will be done After every 7 days of treatment in each group Total duration of treatment plan will be 30 days.
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