Quercus Robur in Reducing the Craving for Alcohol.
- Conditions
- Alcohol dependence,
- Registration Number
- CTRI/2023/10/059212
- Lead Sponsor
- National Homoeopathy Research Institute in Mental Health, Kottayam.
- Brief Summary
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|**Title**
**A Pilot, Double-Blinded, Randomized Controlled Trial to Assess the Effectiveness of Quercus Robur Glandium Spiritus Vs Individualized Homoeopathic Medicine in Reducing the Craving for Alcohol.**
|**Short title**
Quercus Robur in Alcohol Dependence- A pilot study.
|**Protocol number**
2.4
|**Study design**
Two-armed, Parallel Group Randomized Controlled Trial.
|**Study duration**
6 months (Pre-trial preparations-1 month+ 2months for enrolment +2 months for follow up+ 1 month for compilation)
|**Study centre(s)**
Regional Research Institute(H), Hyderabad
|**Objective (s)**
To assess the effectiveness of Quercus Robur Glandium Spiritus compared to Individualized Homoeopathy in reducing the Craving for alcohol in Alcohol Dependence Syndrome patients.
|**Number of subjects**
30 subjects (15 for each arm) would be selected from OPD and IPD of NHRIMH, Kottayam.
|**Diagnosis and main inclusion criteria**
Diagnosis shall be made according to ICD-10 criteria.
Subjects of ages 18 to 60 years from various occupations and socio-economic conditions suffering from ADS, willing to quit alcohol.
|**Study product, Dose, regimen**
Dynamic medicinal preparation of Quercus robur and Individualized Homoeopathic medicine in centesimal scale will be given as per the principles of Homoeopathy shall be administered orally in pills form
|**Statistical methodology**
Student’s *t*-test, and any other appropriate statistical tests as applicable by using SPSS software, version-20.0/ Statscraft software
|**Proposed tools/ scales for the study**
Screening-AUDIT, CIWA-Ar; Severity assessment-SADQ, PACS
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
- Fulfilling ICD-10 diagnostic criteria for Alcohol dependence 2.
- Patients willing to quit alcohol 3.
- Written informed consent.
1.Patients with severe systemic illness 2.Cases with other substance abuse 3.With co-morbid severe psychiatric illness 4.Patients who had previously suffered severe withdrawal symptoms 5.Pregnant women and lactating mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Penn Alcohol craving Scale (PACS) 0,1,2,3,4,8 weeks
- Secondary Outcome Measures
Name Time Method Severity of Alcohol Dependence Scale-SADQ 0,1,2 MONTHS
Trial Locations
- Locations (1)
Regional Research Institute (H), Hyderabad
🇮🇳Hyderabad, TELANGANA, India
Regional Research Institute (H), Hyderabad🇮🇳Hyderabad, TELANGANA, IndiaDr Deepthi GillaPrincipal investigator8111990221drdeepthigilla@gmail.com