| CTRI Number |
CTRI/2026/02/104384 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Unani Intervention in Fatty liver |
|
Scientific Title of Study
|
Unani Intervention in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) |
| 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 Suheena Khanday |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Regional research institute of unani medicine habak naseem bagh srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006219033 |
| Fax |
|
| Email |
suheena.ccrum@ccrum.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suheena Khanday |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Regional research institute of unani medicine habak naseem bagh srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006219033 |
| Fax |
|
| Email |
suheena.ccrum@ccrum.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suheena Khanday |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Regional research institute of unani medicine habak naseem bagh srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006219033 |
| Fax |
|
| Email |
suheena.ccrum@ccrum.res.in |
|
|
Source of Monetary or Material Support
|
| Cental Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Cental Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, 61-65, Institutional area, Opp. D-Block, Janakpuri, New Delhi, pin code-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ministry of Ayush |
Ayush Bhavan, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suheena khanday |
Regional Research Institute of Unani Medicine, Habak, Naseem bagh |
Regional research institute of unani medicine habak naseem bagh srinagar
Srinagar
JAMMU & KASHMIR |
7006219033
suheena.ccrum@ccrum.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Regional Research Institute of Unani Medicine srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E756||Lipid storage disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Arq Biranjasif and Qurs Afsanteen |
Qurs Afsateen is an Unani pharmacopeial formulation which will be given to patients in tablet form orally, with a dose of two tablets twice daily after meals. Arq Biranjasif is also an Unani pharmacopeial formulation will be given orally in distillate form at a dose of 125 ml twice daily along with Qurs Afsanteen. These drugs will be given for a duration of eight weeks. |
| Comparator Agent |
Group B:Qurs Afsateen, Arq Baranjasif and Aab Nakhood |
Aab-e-Nakhood 250 ml (Chickpea infusion) is to be taken early in the morning, along with Qurs Afsanteen, two tablets to be taken twice daily with Arq-e-Biranjasif 125 ml, for a total duration of eight weeks. |
| Comparator Agent |
Group C:Aab Nakhood + Qurs Afsanteen + Arq Biranjasif and Riyazat (Exercise)for 30 minutes daily for 8 weeks |
In this group, Aab Nakhood will be administered orally at a dose of 250 ml once daily in the early morning. Qurs Afsateen, at a dose of two tablets, along with Arq Biranjasif 125 ml, will be given twice daily. In addition, Riyazat (excercise) which is also one of the regimenal therapy in Unani Medicine will be performed daily for 30 minutes. This treatment regimen will be continued for a duration of eight weeks. |
| Comparator Agent |
Group D:Vitamin E capsule 400mg |
In this group Vitamin E 400 mg (440 IU) capsule will be given once daily for a duration of eight weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders, diagnosed with Grade I or Grade II non-alcoholic fatty liver disease on ultrasonography, having mild to moderate elevation of liver enzymes (ALT and AST), and with a body mass index between 25 and 35 kg/m² will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients having severe somatic diseases such as serious respiratory, circulatory, or endocrine disorders, hepatic or renal insufficiency, hepatitis B or C or any other chronic liver disease, those with a history of drug or alcohol abuse, patients on long-term corticosteroid therapy or hepatotoxic drugs, pregnant or lactating women, and patients with cirrhosis, malignancy, or autoimmune hepatitis will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the effectiveness of Unani therapeutic modalities Ilaj bil Dawa (Pharmaco Therapy), Ilaj bil Ghiza (Dietotherapy), and Riyazat (Exercise) in combination with each other, versus standard allopathic treatment in improving hepatic steatosis and liver function in patients with NAFLD.
|
baseline and after completion of study i.e.8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To explore correlations between traditional Unani diagnostic concepts (e.g., Mizaj, Balgham predominance) and clinical/laboratory outcomes in NAFLD patients.
2. To determine the safety and tolerability of Unani interventions compared to standard therapy by monitoring adverse events and treatment adherence.
3. To assess the impact of Unani treatments and allopathic therapy on metabolic parameters such as BMI, FBS, Lipid profile, Insulin level
4. To develop Standard Operating Procedures (SOPs) for the implementation of Riyazat
|
Before and after the eight-week clinical trial |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/03/2026 |
| 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="1"
Months="6"
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
|
This study is a prospective, randomized, open-label, controlled, interventional clinical trial to be conducted at the Regional Research Institute of Unani Medicine (RRIUM), Srinagar, with a sample size of 120 patients diagnosed with non-alcoholic fatty liver disease (NAFLD). The study aims to evaluate and compare the effectiveness and safety of three Unani treatment modalities—Ilaj bil Dawa (drug therapy), Ilaj bil Ghiza (dietotherapy), and Ilaj bil Tadbeer (regimenal therapy)—with standard allopathic management. Eligible participants will be randomized into four groups: Group A will receive Qurs Afsanteen with Arq Biranjasif; Group B will receive Aab Nakhood along with Qurs Afsanteen and Arq Biranjasif; Group C will receive Aab Nakhood, Qurs Afsanteen, Arq Biranjasif, and daily Riyazat; and Group D will receive Vitamin E as standard care, each for a duration of eight weeks, followed by a two-week follow-up period. The total study duration will be one year and six months, including recruitment, intervention, and follow-up. Clinical, laboratory, inflammatory, biomarker, and imaging parameters will be assessed at baseline and at the end of treatment, along with periodic clinical evaluations at predefined intervals. Primary outcomes include improvement in fatty liver grade, liver enzyme levels, and anthropometric measures, while secondary outcomes assess inflammatory markers, metabolic parameters, insulin sensitivity, quality of life, and safety. Data will be collected using validated case record forms and analyzed using appropriate statistical methods. |