A clinical trial to study the effect of an ayurvedic indigenous preparation in the alcoholic patients
- Conditions
- Health Condition 1: null- Madatyaya(alcohol Dependence)
- Registration Number
- CTRI/2017/10/010226
- Lead Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with lakshanas of samanya madatyaya [symptoms of alcohol dependence]
2.Male or a non-pregnant/non-nursing female between 20 and 70 years of age
3.Subjects fulfilling the criteria for alcohol dependence according to ICD-10
4.Self-report of minimum 50 percent heavy drinking days (5 and 4 daily standard drinks or more for males and females, respectively) during a 60 day period, within the last 90 days before screening
5.Be willing to give informed consent and comply with study procedures.
Subjects suffering from organic brain diseases.
•Current use of any psychoactive medication
•Subjects fulfilling ICD-10 criteria for the following axis 1 disorders: Schizophrenia, bipolar disorder, major depression or any other substance dependence disorder (excluding nicotine)
•Previous withdrawal-induced delirium tremens or seizures
•Presence of any serious somatic disorder e.g. liver cirrhosis
•Presence of any previous heart disease of clinically significant ECG abnormality e.g. arrhythmias, bundle branch block or QT interval or T wave alterations
•Use of any illegal narcotic drugs the last 30 days before screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method