A clinical trial to study the effectiveness of dhattura lavana, a folklore medicine in the management of patients of alcoholic dependence
Phase 3
Not yet recruiting
- Conditions
- Madatyaya (Alcoholic Dependence)
- Registration Number
- CTRI/2018/07/014802
- Lead Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
- Brief Summary
The current study will be open labeled single arm (uncontrolled) exploratory clinical trial at outpatient department and inpatient department basis with pre and post-test design. Included 30 patients will be treated with Dhattura saindhava lavana, conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, located in district headquarter in Southern India. 2.5 gram of dhattura lavana along with butter milk after food will be providing to 30 patients. The primary outcome is to reduce the dependency of alcohol in patients and the secondary outcome is to maintain the liver function within normal limits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 1.male or a non pregnant/non nursing female between 20 and 70 years of age.
- 2.subjects fulfilling the criteria for alcohol dependence according to ICD-10.
- 3.Be willing to give informed consent and comply with study procedures.
Exclusion Criteria
- Subjects suffering from organic brain diseases.
- 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 Presence of diseases like diabetes mellitus, HIV,HbSag,Ishaemic Heart Diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduce the dependency of alcohol.Parameters used to assess the reduction in dependency is by alcohol dependence scale and LFT 37 days
- Secondary Outcome Measures
Name Time Method maintain liver function within normal limits
Trial Locations
- Locations (1)
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
🇮🇳Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital🇮🇳Hassan, KARNATAKA, IndiaDr Ajith KumarGPrincipal investigator8281664144drakg1991@gmail.com