To study the effect of Habb-e-Ghafis in patients with Non-Alcoholic fatty liver disease

Phase 2

Not yet recruiting

Conditions: Fatty (change of) liver, not elsewhere classified,

Registration Number: CTRI/2022/01/039497

Lead Sponsor: Central Council for Research in Unani Medicine New Dehli

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 â€“ 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 â€˜westâ€™, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

Ultrasonography (USG) documented grade 1 (mild) and grade 2 (moderate) non-alcoholic fatty liver disease.
Patients with dull ache/heaviness in the right hypochondriac region.
Patients irrespective of gender.
Patients in the age group of 20 to 60.
Body Mass Index (BMI) < 35 kg/m2.
Patients willing to sign written informed consent.

Exclusion Criteria

Patients below the age of 20 years and above 60 years.
Grade 3 fatty liver or above.
Prior diagnosis of chronic liver disease other than NAFLD including autoimmune, viral and alcoholic liver disease.
Patients having fulminant hepatitis and drug induced hepatitis.
Prior diagnosis of liver cirrhosis.
History of liver transplantation.
Body Mass Index (BMI) > 35kg/m2 8.
Pregnant or breastfeeding mothers.
Active case of malignancy.
Patients having cholelithiasis or cholecystitis.
Patients with cardiovascular or renal diseases.
Unwillingness or inability to fulfill the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in signs and symptoms of non alcoholic	45 Days
fatty liver disease	45 Days

Secondary Outcome Measures

Name	Time	Method
Radiological and biochemical assessment	1. Ultrasonography (USG) Abdomen/Pelvis (Liver span)

Trial Locations

Locations (1): Regional Research Institute of Unani Medicine
🇮🇳
JAMMU, & KASHMIR, India
Regional Research Institute of Unani Medicine
🇮🇳JAMMU, & KASHMIR, India
Dr Nida Mehraj
Principal investigator
9682179404
nidamehraj61@gmail.com