| CTRI Number |
CTRI/2024/05/067339 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Hepatitis with Indigenous drugs |
|
Scientific Title of Study
|
A Clinical study on Yakrit vikara w.s.r to Hepatitis and its management with Indigenous drugs |
| 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 Soumya Sucharita Sarangi |
| Designation |
PG SCHOLAR |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
9090002077 |
| Fax |
|
| Email |
sarangisoumya0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pragya Priyadarsini Mallik |
| Designation |
Professor & HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
9437212898 |
| Fax |
|
| Email |
pragya2506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pragya Priyadarsini Mallik |
| Designation |
Professor & HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
9437212898 |
| Fax |
|
| Email |
pragya2506@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya
VIP road
Puri- 752002
Odisha
India |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Sucharita Sarangi |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri |
| 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 Soumya Sucharita Sarangi |
Gopabandhu Ayurveda Mahavidyalaya |
OPD & IPD of Department Of Kayachikitsa
VIP Road
Puri
752002
Puri
ORISSA |
9090002077
sarangisoumya0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Gopabandhu Ayurveda Mahavidyalaya, & Hospital, Puri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K701||Alcoholic hepatitis. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Liv 52 hb, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kamalahara yoga, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Drug induced hepatitis
Hepatitis A & E
Alcohol induced hepatitis |
|
| ExclusionCriteria |
| Details |
Hepatitis with other metabolic disorders
Lactating & pregnant women
auto-immune hepatitis
Hepatitis B,C,D |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get the billirubin quantity to normal levels and to cure the echogenesity of liver parenchymal cells |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the elevated liver enzymes and viral load |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/05/2024 |
| 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
|
Clinical study on Yakrit vikar wsr to Hepatitis is a Randomised, parallel group multiple arm trial of 3 month duration with Indigenous drugs. The primary outcome of this trial is to cure hepatitis and the secondary outcome is to reduce the elevated liver enzymes and viral load |