| CTRI Number |
CTRI/2024/07/070631 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the effect of Bilwadi Agada to protect the liver from alcohol damage A Clinical study |
|
Scientific Title of Study
|
Evaluation of Hepatoprotective Activity of Bilwadi Agada in Alcoholic Liver Diseases
A Clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjana L Siddapur |
| Designation |
Associate Professor |
| Affiliation |
SANJEEVINI AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Agada tantra evam Vidhi Vaidyaka Sanjeevini Ayurveda Medical College and Hospital Dr K S Sharma campus Basveshwara nagar Gokul road Hubballi Dharwad Karnataka
Dharwad
KARNATAKA
580030
India |
| Phone |
8147256942 |
| Fax |
|
| Email |
anjanaraddi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjana L Siddapur |
| Designation |
Associate Professor |
| Affiliation |
SANJEEVINI AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Agada tantra evam Vidhi Vaidyaka Sanjeevini Ayurveda Medical College and Hospital Dr K S Sharma campus Basveshwara nagar Gokul road Hubballi Dharwad Karnataka
KARNATAKA
580030
India |
| Phone |
8147256942 |
| Fax |
|
| Email |
anjanaraddi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnjana L Siddapur |
| Designation |
Associate Professor |
| Affiliation |
SANJEEVINI AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Agada tantra evam Vidhi Vaidyaka Sanjeevini Ayurveda Medical College and Hospital Dr K S Sharma campus Basveshwara nagar Gokul road Hubballi Dharwad Karnataka
KARNATAKA
580030
India |
| Phone |
8147256942 |
| Fax |
|
| Email |
anjanaraddi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevini Ayurveda Medical College and Hospital
Dr K S Sharma campus Basaveshawara nagar Gokul road Hubbali 580030 Dharwad Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sanjeevini Ayurveda Medical College and Hospital |
| Address |
Dr K S Sharma campus
Basaveshwara Nagar
Gokul Road
Hubballi 580030 |
| 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 Anjana Siddapur |
Sanjeevini Ayurveda Medical College and Hospital |
Department of Agada tantra evam Vidhi vaidyaka Dr K S Sharma campus
Basaveshwara Nagar
Gokul Road
Hubballi 580030
Dharwad
KARNATAKA |
8147256942
anjanaraddi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjeevini Ayurveda Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K709||Alcoholic liver disease, unspecified. Ayurveda Condition: MADATYAYA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwaadi Agada, Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Liv 52, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patient having history of Chronic alcoholism and Jaundice
Serum Bilirubin in range of 2 to 3 mg/dl
Patient within the age group 30 to 60years
Male patients will be selected for the study
|
|
| ExclusionCriteria |
| Details |
Patients with complications of Liver disorders – Cirrhosis of liver
Systemic disorders
If HBsAg positive and Hepitits A positive
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparative study will be done on 30 samples to evaluate the effect of Bilwadi Agada and Liv 52 in alcoholic liver diseases |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the comparative effect of bilwadi agada & Liv 52 will be assessed based on CBC LFT USG parameters |
one year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2024 |
| 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="3"
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
|
In our clinical research work trial drug is bilwaadi agada in alcoholic liver diseases. The study will be conducted on 30 patients on the basis of IPD OPD medical camp patients. Investigations like CBC LFT USG will be conducted before and after the treatment. Later Bilwaadi agada will be given for 3 months observation for 3 months and total trial period is 1 year. The study aims to observe the efficacy of Bilwaadi agada on Alcholic liver diseases. |