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CTRI Number  CTRI/2022/01/039497 [Registered on: 17/01/2022] Trial Registered Prospectively
Last Modified On: 14/01/2022
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 the effect of Habb-e-Ghafis in patients with Non-Alcoholic fatty liver disease 
Scientific Title of Study   Evaluating the therapeutic efficacy of Habb-e-Ghafis in Non-alcoholic fatty liver disease, a randomised, single blind, standard controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nida Mehraj 
Designation  PG Scholar 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9682179404  
Fax    
Email  nidamehraj61@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zaffar Hussain 
Designation  Professor Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zaffar Hussain 
Designation  Professor Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine New Dehli 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine New Dehli 
Address  Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir, Srinagar. CCRUM New Dehli 
Type of Sponsor  Research institution 
 
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 Nida Mehraj  Regional Research Institute of Unani Medicine  Moalajat OPD-1, Ground floor, Department of Moalajat, RRIUM, Naseembagh Campus University of Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR 
9682179404

nidamehraj61@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM Srinagar  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 
Intervention  Habb-e-Ghafis  Habb-e-Ghafis is a Unani pharmacopeial preparation. The preparation contains Sibr (Aloe barbadensis Mill) (exudate), Usara-e-Ghafis (Agrimonia eupatoria) (Extract of Gul-e-Ghafis), Post-e-Halela Zard (Terminalia chebula) (Pericarp of mature fruit), Aab-e-Karafs (Apium graveolens L.). Habb-e-Ghafis 3 pills TDS, each pill weighing 500 mg shall be given orally for 45 days.  
Comparator Agent  Vitamin E (Tocopherol)  Vitamin E 400mg shall be given twice a day orally for 45 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Ultrasonography (USG) documented grade 1 (mild) and grade 2 (moderate) non-alcoholic fatty liver disease.
2. Patients with dull ache/heaviness in the right hypochondriac region.
3. Patients irrespective of gender.
4. Patients in the age group of 20 to 60.
5. Body Mass Index (BMI) < 35 kg/m2.
6. Patients willing to sign written informed consent.
 
 
ExclusionCriteria 
Details  1. Patients below the age of 20 years and above 60 years.
2. Grade 3 fatty liver or above.
3. Prior diagnosis of chronic liver disease other than NAFLD including autoimmune, viral and alcoholic liver disease.
4. Patients having fulminant hepatitis and drug induced hepatitis.
5. Prior diagnosis of liver cirrhosis.
6. History of liver transplantation.
7. Body Mass Index (BMI) > 35kg/m2
8. Pregnant or breastfeeding mothers.
9. Active case of malignancy.
10. Patients having cholelithiasis or cholecystitis.
11. Patients having Diabetes Mellitus.
12. Patients with cardiovascular or renal diseases.
13. Unwillingness or inability to fulfill the protocol.
14. Patients who fail to give consent.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Relief in signs and symptoms of non alcoholic
fatty liver disease 
45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Radiological and biochemical assessment
1. Ultrasonography (USG) Abdomen/Pelvis (Liver span)
2. Liver Function Test (Sr. Bilirubin, SGOT, SGPT, ALP, Total Proteins)
3. Lipid Profile (Total cholesterol, Sr. Triglycerides, HDL, LDL, VLDL)
ECG, Haematological and Biochemical assessment in view of safety evaluation 
45 Days 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   25/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver disorders worldwide. Non-alcoholic fatty liver disease (NAFLD) is an umbrella term that includes a range of conditions including non-alcoholic steatohepatitis (NASH). It exists as a spectrum from steatosis (which is stable) to steatohepatitis or non-alcoholic steatohepatitis (NASH) (cellular ballooning, necroapoptosis, inflammation and fibrosis) which progresses to cirrhosis in 15-20% cases. This disease is now recognized worldwide as a potentially serious condition, which can progress to cirrhosis, liver failure, and hepatocellular cancer.  The condition is defined as fatty infiltration of the liver amounting to greater than 5% by liver weight or the presence of over 5% of hepatocytes loaded with large fat vacuoles, in the absence of other causes of fatty liver disease such as alcohol. The predominant lipid that accumulates in hepatic steatosis is triglyceride.  Simple steatosis is benign, whereas patients with NASH can advance to cirrhosis and hepatocellular carcinoma and have a higher chance of developing atherosclerosis, cardiovascular diseases and diabetes mellitus.

NAFLD/NASH is important for several reasons. The most important is the high prevalence in many populations – North and South America, much of Asia and Western Pacific (including Australia) the Middle East and Europe. NASH has been referred to as a disease of the ‘west’, but altered socioeconomic circumstances and the related changes in food intake, food choices and physical activity may each play a role. It is the commonest cause of abnormal liver tests. Certain metabolic conditions like obesity, Type 2 diabetes mellitus or hyperinsulinemia, hypertension, hyperlipidemia (especially hypertriglyceridemia), polycystic ovarian disease are associated with Non-alcoholic fatty liver disease. A strong association between NAFLD and the components of metabolic syndrome suggests that NAFLD is the hepatic manifestation of metabolic syndrome. The worldwide prevalence of NAFLD in the general population is estimated to be 20 to 30% in western countries and 5 to 18% in Asia. Prevalence of NAFLD in the general population in India fluctuates from 9% to 35% with lower prevalence in rural areas. NAFLD is largely associated with dietary excess, inactivity and being overweight. The prevalence and severity of NAFLD/NASH increase with age. NAFLD is well documented in children. It is more common in boys than girls (2: 1). Consistent with a strong inherited component, there is a high prevalence of NAFLD among the adult relatives of affected children. The highest prevalence is in age group 40 to 49 years.

In Unani system of medicine the disease is not as such clearly mentioned but the disease has been described vividly by various Unani physicians under the heading of su-i-mizaj barid kabid (abnormal/altered cold temperament) and waram al-kabid balghamii (phlegmatic hepatititis). Literally, fatty liver may be denominated as tashahhum al-kabid.

It is both striking and worrisome that NAFLD as yet has no approved pharmacotherapy in modern system of medicine. The mainstay of treatment remains diet and lifestyle change to promote weight loss. Survey of literature indicates many single and compound hepatoprotective drugs can be used in the management of liver disorders. Habb-e-Ghafis is one among those drugs. Hence, the need arises to validate the action of this compound pharmacopeial preparation Habb-e-Ghafis in the management of NAFLD.


 
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