An open clinical trial to evaluate the effectiveness of selective siddha medicines in the management of kaleeral noi (Alcoholic Liver Disease stage I and stage II) among out patients attending ayothidoss pandithar hospital national institute of siddha
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME:
研究概览
简要总结
Background:
Alcoholic liver disease (ALD) is the third most common cause of chronic liver disease, and it has a global burden of mortality(1). The alcoholic liver disease covers a spectrum of disorders beginning from the fatty liver, progressing at times to alcoholic hepatitis and culminating in alcoholic cirrhosis, which is the most advanced and irreversible form of liver injury related to the consumption of alcohol. There are three histologic stages of alcoholic liver disease Alcoholic Fatty Liver or Steatosis ,Alcoholic Hepatitis and Alcoholic Cirrhosis
OBJECTIVE:
PRIMARY OBJECTIVE:
• To evaluate the therapeutic effectiveness of siddha herbal and herbo-mineral formulations of “SEENTHIL CHOORANAM, INJI RASAYANAM AND MANDURATHI KUDINEER” in the management of KALEERAL NOI (ALCOHOLIC LIVER DISEASE STAGE I AND STAGE II) by assessment of reduction in signs and symptoms of the alcholic liver disease stage I and stage II among the out patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.
SECONDARY OBJECTIVE:
• To evaluate the changes in CIWA-Ar scale(20) [Clinical Institute Withdrawal Assessment for Alcohol Revised], Liver Function Test, MDF score(5)[Maddrey Discriminant Function Score],lipid profile and fasting blood glucose of the patients before and after treatment.
• To evaluate the changes in Ultrasonography abdomen(liver)
• To evaluate the changes in Body Mass Index and Waist circumference of the patients before and after treatment.
STUDY DESIGN : An Open Clinical Trial
PRIMARY OUTCOME:
• Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment.
SECONDARY OUTCOME:
• Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment
• Changes in ultrasonography of abdomen(liver)
• Changes in waist circumference and Body Mass Index will be assessed before and after treatment
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Age group: 30-65 years Gender: All gender Patient has the history of alcoholic more than 5yrs and who are Alcohol abstinence with ALD included.
- •Patient having CIWA-Ar scale less than 19 (mild to moderate) Patient having MDF score less than 32 (mild to moderate).
排除标准
- •Pregnancy or lactation Fasting glucose levels greater than 250 mg per decilitre Concomitant disease with reduced life expectancy Hepatic failure Severe psychiatric conditions Drug dependence Patients with known liver diseases such as viral hepatitis, non alcoholic fatty liver, autoimmune disorders, biliary disorder, liver abscess, cirrhosis and malignancy.
结局指标
主要结局
PRIMARY OUTCOME:
时间窗: PRIMARY OUTCOME: | Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment. | SECONDARY OUTCOME: | Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment | Changes in ultrasonography of abdomen(liver) | Changes in waist circumference and Body Mass Index will be assessed before and after treatment
Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment.
时间窗: PRIMARY OUTCOME: | Reduction in signs and symptoms of alcoholic liver disease will be assessed before and after treatment. | SECONDARY OUTCOME: | Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment | Changes in ultrasonography of abdomen(liver) | Changes in waist circumference and Body Mass Index will be assessed before and after treatment
次要结局
- SECONDARY OUTCOME:(Changes in Lipid Profile, MDF Score,Fasting Blood Sugar and Liver Function Test will be assessed before and after treatment)
研究者
Suruthi Balakrishnan
National Institute of Siddha