| 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
|
|
|
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
|
|
|
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.
|
|
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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. |