Clinical evaluation of Bhumyamalaki vati and Shyonaka hima as an adjunct with the standard therapy in chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in HBV DNA levels with ALT normalization after treatment.
研究概览
简要总结
This open-label, two-arm randomized controlled trial aims to evaluate the efficacy of Bhumyamalaki
Vati and Shyonaka Hima as an adjunct with the standard therapy in patients with chronic Hepatitis B who falls within the gray zone( indeterminate phase). Thirty patients aged 18–65 years with ALT levels ranging from 41-82U/L
And a low level of HBV DNA, i-e less than 20,000IU/ml for HBeAg positive patients and less than 2000IU/ml for HBeAg negative patients, will be enrolled from the OPD and IPD of the Kayachikitsa Department, Quadra Institute of Ayurveda. Participants will be randomly allocated into two groups. One group will receive standard supportive therapy, while the other will receive standard supportive therapy along with the Ayurvedic intervention. The treatment duration will be 90 days, with a total study period of 18 months. Assessment will be based on subjective and objective parameters, and the collected data will be statistically analyzed to evaluate clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age group of 18 to 65 years.
- •Patients irrespective of sex, religion and occupation.
- •Patients with ALT levels ranging from the upper limit of normal to twice the upper limit of normal 41 to 82 will be selected.
- •Patients with low level of HBV DNA will be selected less then 20,000IU/ml for HBeAg positive patients and less then 2000IU/ml for HBeAg negative patients.
- •Patients with symptoms and signs of chronic hepatitis B and diagnosed chronic hepatitis B infection will be selected.
排除标准
- •Concurrent infection with hepatitis C, D or other hepatic viral infection , autoimmune hepatitis or alcoholic hepatitis.
- •Significant comorbidities such as liver cirrhosis, renal failure or cardiovascular diseases.
- •Pregnant or breastfeeding women.
- •Decompensated liver disease.
- •Patient suffering from Ascites, hepatic encephalopathy, variceal bleeding.
- •Hepatocellular carcinoma.
- •Patients who have previously taken Interferons or antiviral agents, Corticosteroids,immunosuppressive drug.
结局指标
主要结局
Reduction in HBV DNA levels with ALT normalization after treatment.
时间窗: Evaluation of reduction in viral load (HBV DNA) and ALT levels will be assessed at follow-up visits scheduled on the 30th, 60th, and 90th day after initiation of treatment.
次要结局
- Evaluation of improvement in clinical symptoms, liver enzyme normalization trend, and overall quality of life; along with assessment of safety and tolerability of the intervention.(18 months)
研究者
AKSHITA
Quadra Institute Of Ayurveda And Hospital