Effectiveness of Individualised Homoeopathic Medicines in the management of Psychoses
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Homoeopathic therapeutic intervention in the
研究概览
简要总结
AIM To evaluate the efficacy of individualized Homoeopathic medicine in the management of general and specific symptom dimensions of Psychoses.
PRIMARY OBJECTIVE: To evaluate the efficacy of Homoeopathic therapeutic intervention in the management of Psychoses.
SECONDARY OBJECTIVES: 1. To find out the most commonly indicated remedies in Psychoses. 2. To assess the quality of life of patients before and after Homoeopathic intervention.
NULL HYPOTHESIS (H0): Individualised Homoeopathic medicines are not effective in Psychoses.
ALTERNATIVE HYPOTHESIS (H1): Individualised Homoeopathic medicines have a significant effect on Psychoses.
METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT: Patients of both genders between the age of 18 and 60 shall be screened for symptoms of Psychosis with a screening questionnaire prepared using ICD-10 Diagnostic Criteria for Research at In-patient, Outpatient Departments and Peripheral camps of National Homoeopathy Research Institute in Mental Health, Kottayam. The screening format will be maintained in the OPDs.A detailed case taking will be done on the Case Recording Performa, based on Classical Homoeopathic Principles. After proper analysis and evaluation of symptoms of each case, repertorisation shall be done with Synthesis Repertory using RADAR software. The similimum will be selected on the basis of individualization of the patient as per the reportorial result, in consultation with Materia Medica. Potency starting from 30C shall be administered. Cases will be assessed at baseline with the Brief Psychiatric Rating Scale (BPRS) to determine the severity of the condition. The Quality of life of the subjects will also be assessed with 8 WHOQOL BREF at baseline. The severity of the assessment of psychotic symptoms will be done every month with the BPRS scale and Assessment of quality of life will be done every 3 months with WHOQOL BREF. The outcome of treatment will be assessed according to BPRS and WHOQOL BREF scale before and after administering individualized Homoeopathic medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both genders in the age group of 18-60 years.
- •All cases of psychosis with more than 1month duration diagnosed by the psychiatrist as per ICD-10 criteria.
- •Those patients whose family or relatives are willing to give consent.
排除标准
- •Patients with Organic psychosis.
- •Patients with suicidal and homicidal tendencies.
- •Substance-induced psychotic disorders.
- •Persons under treatment with Antipsychotics.
- •Pregnant and lactating women.
- •Mental retardation with psychotic symptoms.
结局指标
主要结局
To evaluate the efficacy of Homoeopathic therapeutic intervention in the
时间窗: 1 year
management of Psychoses.
时间窗: 1 year
The primary outcome will be assessed every month with BPRS scale. The score on BPRS scale will determine the severity of psychotic symptoms.
时间窗: 1 year
次要结局
- 1. To find out the most commonly indicated remedies in Psychoses.(2. To assess the quality of life of patients before and after Homoeopathic)