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临床试验/CTRI/2022/10/046584
CTRI/2022/10/046584尚未招募3 期

THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN SPECIFIC PHOBIA

Dr JINU M SUNIL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月21日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To determine the change in the intensity of specific phobia after individualized

研究概览

简要总结

Aim:

To find out the effectiveness of individualized homoeopathic medicine in reducing symptoms of specific phobia.

Primary Objective:

To determine the change in the intensity of specific phobia after individualized homoeopathic medicine.

Secondary objective

To find out the change in quality of life of patients with specific phobia after homoeopathic medicines.

HYPOTHESIS

Null Hypothesis (H0)

Homoeopathic remedies are not effective in reducing symptoms of specific phobia

Alternative Hypothesis (H1)

Homoeopathic remedies are effective in reducing symptoms of specific phobia

METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT

All patients who present with fear, anxiety, and avoidance of certain situations at outpatient department of National Homoeopathy Research Institute in Mental Health, Kottayam & peripheral OPDs shall be screened with a preliminary verbal screening by OPD doctors followed by detailed screening by the investigator. After screening, the Psychiatrist will assess the case for diagnostic confirmation. Written informed consent will be taken from each subject. Basic routine investigations will be done at baseline. Appropriate investigations must be done to rule out other symptoms when required. Detailed case taking will be done on the case recording format made for the study. Cases will be assessed by using SEVERITY MEASURE FOR SPECIFIC PHOBIA - ADULT SCALE at baseline and at periodic intervals during monthly follow-ups. WHO QOL questionnaire will be assessed at baseline & every 6 months of the study. Individual totality will be erected on the basis of analysis and evaluation of the case. Repertorisation will be done with synthesis repertory using RADAR OPUS software version. Final selection of remedy will be done after comparison with Homoeopathic Materia Medica. The dose and repetition of medicine will be done based on Homoeopathic principles. The progress will be assessed for a period of 1 month. If improvement stops at a period, next higher potency will be given. If no change takes place at all, the case will be retaken and another remedy will be considered. If any acute complaints arise, acute totality will be taken and the appropriate remedy will be administered. If there are no follow-ups for 3 consecutive visits, telephonic follow-up will be done and if they are not responding or in the absence of further visit the case will be considered as dropped out. The drop out cases if returning for treatment will be given standard care but will not be included in the study. Those who have willingly withdrawn from the study also will be given general treatment in OPD but not considered for the study evaluation. The study will be conducted after the approval from institutional ethical committee and after registration in CTRI.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Cases satisfying specific phobia (F40.2) diagnostic criteria of ICD 10, Age group between 18 to 65 years.

排除标准

  • Cases with life-threatening Systemic illness, Cases with comorbid major psychiatric conditions, Subjects who are pregnant or lactating, Subjects who are under psychotropic medications.

结局指标

主要结局

To determine the change in the intensity of specific phobia after individualized

时间窗: 6 months for enrollment. One year for follow-up and intervention.

homoeopathic medicine

时间窗: 6 months for enrollment. One year for follow-up and intervention.

次要结局

  • To find out the change in quality of life of patients with specific phobia after(homoeopathic medicines.)

研究者

发起方
Dr JINU M SUNIL
申办方类型
Other [self]

研究点 (1)

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