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临床试验/CTRI/2025/06/089585
CTRI/2025/06/089585尚未招募2 期

A PROSPECTIVE OPEN LABEL SINGLE ARM STUDY ON THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINES IN REDUCING THE ABNORMAL INVOLUNTARY MOVEMENTS OF ANTIPSYCHOTIC INDUCED TARDIVE DYSKINESIA

Dr DEEPU C S2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年6月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
38
试验地点
2
主要终点
Assessment of reduction in the severity of TD after Homoeopathic medicines by using AIMS

研究概览

简要总结

This prospective open label single arm study evaluates the effectiveness of Homoeopathic Medicines in reducing the abnormal involuntary movements of anti psychotic induced Tardive Dyskinesia using Abnormal Involuntary Movement Scale(AIMS) Secondary objective include assessing improvements in quality of life of patient through WHO-QOL BREF scale .Patients will be recruited from the Out patient Department(OPD),In patient Department(IPD),and Peripheral Centres of the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, following screening based on Verbal Screening Questioner Enrolment requires psychiatric confirmation ,and informed consent/Assent will be obtained from legally authorised representative in English and Malayalam .Baseline assessment include AIMS for severity, with evaluations conducted monthly and tri-monthly, respectively ,while quality of lifewillbemonitoredusingtheWHO-QOLBREFscale.Adetailedcasehistoryandoneon the case recording format and indicated Homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and in comparison with Homoeopathic Materia Medica. Patients missing follow-ups for three consecutive months will be considered dropouts and will receive standard  OPD care but will be excluded from further study evaluation. The study aims to provide effectiveness of Homoeopathy’s role as an adjuvant therapy in Tardive Dyskinesia, assessing its ability to improve symptoms and enhance the quality of life

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Participants of any gender in age group 18-80 yrs Participants having score greater than or equal 2 of AIMS Psychiatric patients who are under antipsychotic treatment for at least 3 months if below 60.

排除标准

  • Those with stereotyped movement disorders Pregnant and lactating women Those with antipsychotic withdrawal emergent dyskinesia Those who are in alcohol withdrawal state.

结局指标

主要结局

Assessment of reduction in the severity of TD after Homoeopathic medicines by using AIMS

时间窗: AIM Scale at baseline and at the end of study (after 6 months )

次要结局

  • To find out the general improvement of the patient(QOL Scale at baseline & at the end of study (after 6 months ))

研究者

发起方
Dr DEEPU C S
申办方类型
Other [self]

研究点 (2)

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