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CTRI Number  CTRI/2024/05/067446 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Unani formulation in fatty liver disorder  
Scientific Title of Study   Efficacy and safety of Qurs-e-Rewand in Metabolic Associated Fatty Liver Disease: A Randomized Controlled Trial 
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 Sabiha Khan 
Designation  PG SCHOLAR 
Affiliation  National Institute Of Unani Medicine 
Address  Department Of Moalajat National Institute of Unani Medicine Kottigepalya, Magadi main Road Bangalore KARNATAKA 560091 India
magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  9131339448  
Fax    
Email  sabihakhan9826@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Mobeen 
Designation  Assistant Professor Department of Moalajat 
Affiliation  National Institute Of Unani Medicine 
Address  Department Of Moalajat National Institute of Unani Medicine Kottigepalya, Magadi main Road Bangalore KARNATAKA 560091 India
magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  8123143721  
Fax    
Email  dr.mobeen@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Mobeen 
Designation  Assistant Professor Department of Moalajat 
Affiliation  National Institute Of Unani Medicine 
Address  Department Of Moalajat National Institute of Unani Medicine Kottigepalya, Magadi main Road Bangalore KARNATAKA 560091 India
magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  8123143721  
Fax    
Email  dr.mobeen@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Moalajat National Institute of Unani Medicine Magadi Main Road Bangalore, Karnataka 560091 India  
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sabiha Khan  National Institute of Unani Medicine Bangalore  Room no 1 & 2 Department of Moalajat National Instiitute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9131339448

sabihakhan9826@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethies Committee (IEC)for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Wheat flour as a placebo 3.5 gms in capsule form in two divided doses 
Intervention  Qurs e Rewand containing Rheum emodi Wall. Rubia cordifolia Linn. Laccifer lacca. Apium graveolens Linn. Pimpinella anisum Linn. Gentiana Olivier.   3.5 gms powder of Qurs-e-Rewand formulation in capsule form in two divided doses for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Fatty liver Grade one and Grade two with Any One of the following Criteria. Body Mass Index greater or equal to 23 in Asian. Diagnosed patient of type 2 Diabetes.
Or Fatty liver Grade one and Grade two detected by Ultrasound, blood biomarkers with Any two of the following risk factors. Waist circumference greater than or equal to 90 and 80 cm in Asian men and women respectively. Blood pressure greater or equal 130 upon 85 mmHg or specific drug treatment. HDL level less or equal to 40 mg/dl in males, less or equal to 50 mg/dl in females or specific drug treatment. Triglycerides greater or equal to 150 mg/dl or specific drug treatment. Prediabetes that is FBS 100 to 125 mg/dl. Homeostasis model assessment of insulin resistance score greater or equal to 2.5. Plasma high-sensitivity C-reactive protein level greater than 2 mg/L.
Age between 18 to 60 years of either gender.
Patient willing to participate and follow the protocol.
 
 
ExclusionCriteria 
Details  Hepatic steatosis in adults less than 5%. Patients with uncontrolled type 2 Diabetes. (FBS greater or equal to 250mg/dl, PPBS greater than 350mg/dl or HbA1c greater or equal to 10%). Patients with uncontrolled Hypertension greater or equal to160 upon 100 mmHg). Patients with uncontrolled lipid profile Total cholesterol greater than 250 mg/dl, Triglycerides greater than 499 mg/dl, LDL greater than 189 mg/dl, HDL greater than 70 mg/dl. Patients suffering from severe cases of liver disease Serum Bilirubin greater than 10mg/dL, AST and ALT greater than 400U/L. Patients suffering from chronic liver disease and cancer. Severe cases of heart, kidney, lung, or other systemic diseases. Pregnant or lactating female. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of Liver Steatosis Grade and improvement in the Serum concentration of Liver Enzymes.
 		 56 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of subjective Parameters (Indigestion, Fatigue, Right upper quadrant discomfort, Hepatomegaly)
Assessment of Quality-of-Life, World Health Organization Quality of Life Questionnaire (WHOQOL-BREF).
Anthropometric indices: Body weight, Waist Circumference, BMI.
Glycemic indices: FBS, PPBS, HbA1c.
Lipid Profile: TG, TC, HDL, and LDL.
Blood Pressure; SBP and DBP.
 		 56 days 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/07/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

At the screening visit, a brief medical history will be acquired from each subject, and general physical and vital parameters, hematologic profiles, and body weight will be recorded. Patients of Metabolic Associated Fatty Liver Disease fulfilling the inclusion criteria will be included in study. Patients will be blinded for the study. Participants will be randomly assigned to either experimental group or control group with a 1:1 group using the random allocation software. In the test group 3 capsules of Qurs-e-Rewand 600 mg each will be given twice daily. Conversely, in the control group wheat flour as a placebo will be given in the same way. At each follow up patients will be assessed clinically for efficacy outcome and safety on objective parameters. The safety of the drugs will be ensured by monitoring the hematological and biochemical tests at baseline and after treatment. The data will be statistically analyzed and compared with appropriate statistical tests. The significant level of p <0.05 will be taken for effect.

 

 
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