| CTRI Number |
CTRI/2024/04/065391 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| 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
|
Treatment of Fatty Liver Disease with Unani Medicine |
|
Scientific Title of Study
|
An Open Label, Randomized, Controlled Clinical Study to Evaluate the Therapeutic Efficacy of a Specific Unani Formulation in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Wasi Akhtar |
| Designation |
PI (Asst. Professor) |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India
South
DELHI
110062
India |
| Phone |
9027570265 |
| Fax |
|
| Email |
drmdwasiakhtar@jamiahamdard.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulnaz Azmi |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India
South
DELHI
110062
India |
| Phone |
9451066452 |
| Fax |
|
| Email |
gulnaz.azmi01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulnaz Azmi |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India
South
DELHI
110062
India |
| Phone |
9451066452 |
| Fax |
|
| Email |
gulnaz.azmi01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard (Deemed to be University), New Delhi, India-110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Dept. of Moalajat, School of Unani Medical Education and research, Jamia Hamdard, New Delhi 110062 |
| 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 Md Wasi Akhtar |
Majeedia Unani Hospital |
Moalajat (Medicine) OPD and IPD, Majeedia Unani Hospital, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI |
9027570265
drmdwasiakhtar@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Unani Formulation |
The Unani formulation containing extracts of Revand Chini, Afsanteen, Qust and Luk.
2 capsules of the Unani formulations will be given orally in empty stomach twice daily for 3 months. |
| Comparator Agent |
Vitamin E |
Vitamin E 400 mg will be given twice daily orally for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of grade 1 and grade 2 Fatty Liver (up-to 290 db/m in QUS/ Fibroscan)
2. Patients willing to participate and ready to sign the written informed consent.
3. Patients diagnosed as having fatty liver based on the ultrasonography report.
4. Patients with/ without clinical signs and symptoms.
|
|
| ExclusionCriteria |
| Details |
1. Patients having documented fatty liver grade 3 or above.
2. Use of alcohol or any other drug abuse.
3. Patients diagnosed with any coexisting liver disease.
4. Pregnant and lactating women.
5. Patients suffering with Hypertension, CKD, CAD, CLD or uncontrolled DM, Hypothyroidism.
6. Patient having immune-compromised status.
7. Patient using lipid lowering drugs or dietary supplements within the last 3 weeks.
8. Oral contraceptives & corticosteroids.
9. Neurological disorders like epilepsy or psychiatric disorders.
10. Patient having history of Pancreatitis.
11. Acute hepatitis with raised serum bilirubin.
|
|
|
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 |
| Improvement in Fatty liver grade assessed by QUS. |
1st day and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Liver Function Test,
Improvement in Lipid profile |
1st day and 90th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients of Non-Alcoholic Fatty liver Disease upto Grade II, fulfilling the Inclusion criteria and Exclusion criteria will be divided into two groups. Group A patients will be given Unani formulation in a dose of 2 capsules twice daily orally in empty stomach for 90 days. Group B patients will be given Vitamin E in a dose of 400 mg orally twice daily for 90 days. The assessment of Primary objective (Fatty liver) will be done through QUS (Quantification Ultra Sound) on day 1 and day 90. The assessment of LFT and Lipid profile will also be done on day 1 and day 90 to see the effect on secondary objectives. |