Effectiveness of BooZNil in the Management of Alcohol Dependence: A Prospective Non-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To observe and document Drinking Behavior assessment - abstinence rate of study subjects over 30th ,60th ,90th day of BooZNil.
研究概览
简要总结
Effectiveness of BooZNil in Managing Alcohol Dependence
Study Design A single arm, open label, prospective clinical trial conducted over six months.
Primary Objective To evaluate the effectiveness of BooZNil in achieving and maintaining abstinence in alcohol-dependent individuals over 12 weeks by assessing:
Abstinence rates
Changes in serum carbohydrate-deficient transferrin (CDT) levels
Improvement in liver function test parameters
Secondary Objectives
Evaluate reductions in alcohol cravings using Alcohol Craving Questionnaire (ACQ) and Obsessive Compulsive Drinking Scale (OCDS)
Assess the safety and tolerability of BooZNil™ by monitoring adverse events and withdrawal symptoms
Sample Size30 male participants aged 18 to70 years diagnosed with alcohol dependence as per ICD10 criteria.
Intervention BooZNil syrup (herbal formulation) administered over 12 weeks.
Inclusion Criteria
Diagnosed with alcohol dependence (ICD-10 criteria)
Abstinent for at least 5 days before recruitment
CIWA-ar score <10
Exclusion Criteria
Severe comorbid conditions
Concurrent use of psychotropic medications
History of significant adverse reaction to herbal formulations
Outcome Measures
Primary: Abstinence rate, CDT levels, liver function improvement
Secondary: Reduction in craving scores, adverse event monitoring
funded by MMC Pharmaceuticals, Chennai
Trial Duration 6 months
Ethical ApprovalObtained from the Institutional Ethics Committee.
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 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants willing to be abstinent from alcohol for at least 5 days before entry into the study.
- •Participants expected to have good social support or a family environment to ensure treatment compliance and follow-up Diagnosis as per ICD-10 criteria for alcohol dependence.
- •Clinical institute withdrawal assessment for alcohol revised (CIWA-ar) score less than 10 Participants willing to give informed consent.
排除标准
- •Participants with cirrhosis of the liver.
- •Participants with Liver function test (LFT) values more than three times the normal values Will be excluded from the study.
- •Participants with any chronic systemic illness or with life-threatening disease.
- •Participants with other substance abuse/addiction.
- •Participants with any co-morbid psychiatric disorder.
结局指标
主要结局
To observe and document Drinking Behavior assessment - abstinence rate of study subjects over 30th ,60th ,90th day of BooZNil.
时间窗: Baseline, 30th, 60th and 90th day of follow up.
To assess the Percentage (%) of study subjects with complete abstinence of alcohol consumption over treatment period of 12 weeks and Cumulative abstinence duration (defined as the number of days of abstinence during the treatment period).
时间窗: Baseline, 30th, 60th and 90th day of follow up.
To estimate serum carbohydrate deficient transferrin over baseline and 30th ,60th and 90th day of therapy.
时间窗: Baseline, 30th, 60th and 90th day of follow up.
To evaluate the effect of BooZNil in the liver function tests from baseline to 30th, 60th and 90th day of follow up.
时间窗: Baseline, 30th, 60th and 90th day of follow up.
次要结局
- To assess scores of cravings as rated by Alcohol Craving Questionnaire (ACQ) and Obsessive-Compulsive Drinking Scale (OCDS) from baseline to 30th, 60th and 90th day of BooZNilTM treatment.(To observe and assess any withdrawal symptoms and adverse events during study period.)
研究者
Priyadharshini Ananthathandavan
SRM College of Pharmacy SRMIST