A double blind, placebo controlled comparative, randomized study to evaluate efficacy & Safety of Colebrookea Oppositifolia (Aceteoside) in acute hepatitis A/B Patients.
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary outcome measures will be improvement in liver function tests, immunological test and liver ultrasound imaging as compared to base line using appropriate statistical test.
研究概览
简要总结
This study is double blind placebo controlled, randomized clinical trial to evaluate the efficacy & safety of Colebrookea Oppostitifolia (Aceteoside) in acute hepatitis patients A/B. Acetoside is aqueous Extract obtained from the dried & powdered aerial parts of the Colebrookea Plant. Patients meeting inclusion criteria will be randomized & divided in two groups, one group will receive Acteoside 25 mg T.D. S and other group placebo 25 mg TDS for a period of Six weeks, the primary out come measure will be statistical improvement in liver function tests like S.Bil, S.Alt, S.Ast, S. Albumin S. Alkaline phosphate & prothrombin time these will be assessed at base line, 1 wk, 2 wks, 4 wks, & 6 wks.Immunological Tests-1 gm anti HBC anti body, S.HBeAG, and 1 gm Anti HAV anti body, HBsAg, Anti HBs antibody , S.HBeAg, ANTI Hbe Ab, 1 gm ANTI HAV antibody and liver ultrasound imaging. Adverse drug reaction (ADR) monitoring will be done throughout the study as per the pharmacovigilance programme.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •1.Individuals between 18-60 years of age of either sex suffering from acute hepatitis A/B.
- •Diagnosis will be made on the basis of clinical history or immunological markers.2.Patients ready to abide by trial procedures and to give informed consent.
排除标准
- •1.Patients over 60 years or less than 16 years of age.2.Pregnant or lactating mothers / complicated with Non A & B Hepatitis or Drug / alcoholic hepatitis / chronic active hepatitis.3.Suspicion of auto – immune disease concomitant presence of disease of Cardiovascular System, renal or haemopoietic System or mental disease.4.Patients using drugs which are likely to affect liver function tests e.g. NSAID’s, Anticonvulsants, anti-diabeitic, statins , hormones, erythromycin etc.
结局指标
主要结局
The primary outcome measures will be improvement in liver function tests, immunological test and liver ultrasound imaging as compared to base line using appropriate statistical test.
时间窗: 6 weeks onwards
次要结局
- Not Applicable(Not Applicable)