Effectiveness of Ultra high dilution of Chlorpromazinum compared to Individualized Homoeopathic Medicine in reducing Positive symptoms of Schizophrenia - A Single Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Assessment of reduction in positive symptoms of Schizophrenia using Scale for Assessment of Positive Symptoms, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.
Study Overview
Brief Summary
The study is a Single Blind Randomized Controlled Trial conducted at the National Homeopathy Research Institute in Mental Health, Kottayam, with a duration of 18 months (12 months enrollment and 6 months follow-up). The primary objective is to compare the effectiveness of homoeopathic Chlorpromazinum with individualized homoeopathic medicine in reducing positive symptoms of schizophrenia. The primary outcome measure is the reduction in positive symptoms assessed by the SAPS (Scale for the Assessment of Positive Symptoms) score. Secondary outcome measures include evaluating the overall symptom reduction with PANSS (Positive and Negative Syndrome Scale) and assessing the effectiveness of homoeopathic medicine in mitigating side effects of antipsychotic medications using the Glasgow Anti-psychotics Side-effect Scale (GASS). Assessments are planned monthly with SAPS, at baseline and study endpoint with PANSS, and every three months with GASS. Monthly follow-ups will be conducted for up to 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of all genders
- •Ages between 18 and 65 years of age
- •Subjects fulfilling ICD 10 diagnostic criteria of Schizophrenia.
- •Patients under Antipsychotic medication.
Exclusion Criteria
- •Patients with comorbid neuro-psychiatric disorders
- •Patients with serious systemic illness.
- •Pregnant and lactating women.
Outcomes
Primary Outcomes
Assessment of reduction in positive symptoms of Schizophrenia using Scale for Assessment of Positive Symptoms, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.
Time Frame: Every month from baseline till the conclusion of the study(6th month)
Secondary Outcomes
- Assessment of overall improvement in the symptoms of Schizophrenia using Positive and Negative Syndrome Scale, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.(At the baseline and end of the study(6th month))
- Assessment of reduction in the Side-effects of antipsychotic medications using Glasgow Anti-Psychotics Side-effect Scale after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.(Baseline, at 3rd,and conclusion of the study(6th month))
Investigators
Dr S Sudheer Kumar
National Homoeopathy Research Institute in Mental Health