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临床试验/CTRI/2025/01/078881
CTRI/2025/01/078881尚未招募2 期

Efficacy of Qurs e Afsanteen in Non-Alcoholic grade 1 and 2 Fatty Liver Disease: A randomized Placebo Controlled Trial

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
1) Changes in grading of fatty liver (USG)

研究概览

简要总结

Nonalcoholic Fatty Liver Disease (NAFLD) is known to be the most prevalent hepatic disorder that characterized by excessive hepatic fat accumulation, in absence of remarkable alcohol consumption. Frequently linked to other metabolic diseases such as hyperlipidemia, cardiovascular diseases, hepatocellular carcinoma, type 2 Diabetes mellitus and obesity. According to studies, NAFLD and its link to obesity will considerably increase liver related morbidity and mortality by 2030. The prevalence of NAFLD varies among different populations, with the Middle East having the highest rates (32% of the population is thought to be affected), followed by the United States and South America (30%). The estimated prevalence for other regions, including Asia, Europe, and Africa, ranges from 13% to 27%. Nonalcoholic fatty liver disease is considered to be a hepatic manifestation of metabolic syndrome. NAFLD encompasses a spectrum of liver pathology with different clinical prognoses. It is characterized by the simple accumulation of triglycerides within hepatocytes (hepatic steatosis). The most clinically ominous extreme are cirrhosis and primary liver cancer. Current trends of management of Nonalcoholic fatty liver disease include lifestyle modification by Diet and exercise and Thiazolidinediones, biguanides (to increase insulin sensitivity), Statin (to prevent cholesterol synthesis), Antioxidants (oxidative stress is thought to be an important factor for the progression of NAFLD). Biguanides are increasingly being abandoned because of their hepatotoxicity and Thiazolidinediones causes Edema and Congestive Heart Failure, Weight Gain, Fractures, Bladder Cancer, Hepatotoxicity, Diabetic Macular Edema, Increased Ovulation and Teratogenic Effects. Statin causes digestive system problems, muscle pain, sleep problems, low blood platelet count, memory problems, hair loss, hepatitis, pancreatitis, sexual problems.

In view of Unani medicine balghami and saudawi mizaj persons are slow metabolizers due to deficient digestive power. Excessive use of cold and moist food, inadequate quantity and improper timing of food intake produces excess of cold and moist humors after metabolism and also increases coldness and humidity in liver and stomach. that results in weakness of quwwate jaziba and quwwate hadima in liver and weakens digestion. In this condition blood formed is rich in balgham.  Coldness produces Ghaleez and Luzuj Akhlat, further increase in coldness congelate serous humor that is known as Shaham , thick and viscid matter also accumulates in liver and causes inflammation in liver and obstruction in vessels and canals within the liver where chyme metabolized. Grade 1 and 2 of NAFLD in Unani medicine may correlate with Sue mizaj barid ratab maddi in liver (abnormal substantial cold and moist temperament) and grade 3 and higher corelate with Sue mizaj barid yabis maddi in liver that causes obstruction in liver. Unani physicians, advised the use of musakhin, mujaffif , mulattif , muqawwie maida and muqawwie jigger advia to correct the mizaj (temperament) of liver and to restore the quwwate jaziba and hadima of liver and to liquify the accumulated thick and viscid matter in the liver for example qurse rewand, qurse afsanteen, qurse ghafis, dawa al kurkum, qurse luk, kasoos, usare ghafis, Dar chini, qarnfal, rewand chini, asaroon, aneesoon, tukhme karafs etc. Out of these Qurse afsanteen was chosen because of several reasons. First, its efficacious use has been documented in Unani literature. Second, hypolipidemic, hepatoprotective and antioxidant activities has been verified in the ingredients of qurse afsanteen in animal studies.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Non-Alcoholic Fatty liver grade 1(Mild) and grade 2(moderate) based on ultrasonography 2) Patients of both genders 3) Age group of 20 TO 60 years 4) BMI less than 39.9 5) If Alcoholic (Male less than 30gms per day And Female less than 20gms per day).

排除标准

  • Pregnancy and lactation 2)Fatty liver of grade 3rd (severe) and above.
  • Patients with serious co morbid condition BP 140/90 mmHg and liver failure and renal failure and Hepatic cirrhosis and Cancer and other endocrine illnesses and other types of fatty liver disease caused by Alcohol viral or autoimmune hepatitis and Wilson’s Disease and Chronic disease like CHS Decomposed lung diseases and Carrier of HIV 4)BMI more than 39.9 5)Patients on hypolipidemic drugs 6)Recurrent drug use 7)Excessive Alcohol intake (Average alcohol intake Male more than 30gms per day and Females more than 20gms per day) 8)History of infection surgery trauma hospitalization in past 30days 9)Chronic degenerative disease of non-hepatic region 10)Non-compliance with the treatment 11) Failure to follow up or refusal to continue the study protocol 12) History of Drug use like (Amiodarone Methotrexate Corticosteroids Estrogen warfare Anti-convulsions drugs Anti-psychotic drugs Chemotherapy drugs and any medication for liver in past 6 months.

结局指标

主要结局

1) Changes in grading of fatty liver (USG)

时间窗: at baseline (0th day), and 60th day

2)Changes in SGOT and SGPT levels

时间窗: at baseline (0th day), and 60th day

3)Changes in lipid profile

时间窗: at baseline (0th day), and 60th day

次要结局

  • 1)Changes in waist circumference 2) Changes in BMI(at baseline, 15th day, 30th day, 45th day and on 60th day)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mohammed Atiq Raza

National Institute of Unani Medicine

研究点 (1)

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