| CTRI Number |
CTRI/2024/02/063162 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study alcoholic liver disease with unani medicine |
|
Scientific Title of Study
|
A randomized single blind two arm clinical trial of polyherbal unani formulation in the treatment of alcoholic hepatitis in comparison of jigreena capsules |
| 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 Mohammed Junaid Ali |
| Designation |
Pg scholar |
| Affiliation |
Govt Nizamia tibbi college and General Hospital |
| Address |
Op 01, pg department of moalijat, govt Nizamia tibbi college and General Hospital
Hyderabad
TELANGANA
500002
India |
| Phone |
9912329079 |
| Fax |
|
| Email |
drjunaidali2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Abdul khadir Hussaini |
| Designation |
Pg professor |
| Affiliation |
Govt Nizamia tibbi college and General Hospital |
| Address |
Room no.218, pg department of moalijat, govt Nizamia tibbi college and General Hospital
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
drsakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Junaid Ali |
| Designation |
Pg Scholar |
| Affiliation |
Govt.Nizamia Tibbi College and General Hospital |
| Address |
Op 01, pg department of moalijat, govt Nizamia tibbi college and General Hospital
Hyderabad
TELANGANA
500002
India |
| Phone |
09912329079 |
| Fax |
|
| Email |
drjunaidali2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Nizamia Tibbi College and General Hospital |
|
|
Primary Sponsor
|
| Name |
PG Dept of Moalijat |
| Address |
PG Dept of Moalijat, Govt.Nizamia Tibbi College and General Hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohammed Junaid Ali |
Government Nizamia Tibbi college and General hospital |
Speciality OPD No-1, PG Department of Moelijat (General medicine)Charminar,Kotla Alija
Hyderabad 500002
Hyderabad
TELANGANA |
09912329079
000
drjunaidali2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee G.N.T.C HYD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K701||Alcoholic hepatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Unani drug |
Jigreena 1 capsules BD for 45 days |
| Intervention |
Unani drugs |
Each patient is treated with polyherbal unani formulation in form of capsules 3 gm per day containing 1. Rosa domestica (gule surkh), 2.Apium graveolens (tukhme karafs), 3. Chichorium intybus (kasni), 4. Rheum emodi (Revand chini), 5. Bambusa arundinaceae (Tabasheer),6. Agrimonia eupatoria (Gule ghafis),7.Berberis vulgaris (zarishk), 8.Santalum album (sandal safaid),9. Pterocarpus aantalinus(sandal surkh) 10.Areca catexhu(supari), 11. Commiphora mukul(laak), 12. Neputa duperalis(Badyaan) in equal quantity for 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.On going consumption of alcohol more than 40gm per day in female and more than 60gm per day in male.
2.Total serum bilirubin more than 1.2mg/dl
3.ALT more than 50 IU/dl. |
|
| ExclusionCriteria |
| Details |
1.Pateint with Diabates and uncontrolled hypertension, uncontrolled drug addiction,latent tuberculosis.
2.patient with Auto immune disorders.
3.patient with active hepatitis-B and chronic hepatitis-C.
4.patient with increase creatinine level more than 2.5mg/dl. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce ALT (Alanine transaminase) to normal value 50 IU/dl
To reduce total serum bilirubin to normal 1.2mg/dl |
Serum ALT and serum bilirubin at every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce hepatomegaly in alcoholic hepatitis patients |
30 days |
|
|
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)
|
03/03/2024 |
| 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="0"
Days="6" |
|
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
|
Alcoholic hepatitis became one of the serious concern for rising death rates globally.Alcohol is the world’s 3rd largest risk factor for disease burden results in 2.5 million death every year.In this research trail 20 pateint will be given treatment a polyherbal unani formulation 3gm per day for 90 days with every 2 weeks fallow up as control drug and 20 patients will be given jigreena capsules 1.5 gm for 90 days with 2 weeks fallow up and results be compared. |