跳至主要内容
临床试验/CTRI/2024/08/072742
CTRI/2024/08/072742尚未招募3 期

A prospective open label single arm study on Individualized Homoeopathic Medicines in reducing the Challenging Behavior among adults with Intellectual Disability

Nisma K U1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年8月28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
35
试验地点
1
主要终点
Assessment of reduction in the severity of Challenging behavior after the administration of individualized homoeopathic medicine using BPI-S scale

研究概览

简要总结

All patients who present with the symptoms of ID at OPDs, IPDs, peripheral or special camps of NHRIMH, Kottayam shall be screened with Verbal screening Questionnaire.. Those subjects who have done IQ priorly shall be considered and those who have not done their IQ assessment shall be made to do an apriori IQ assessment by the qualified clinical psychologist for the purpose of partial fulfillment of diagnostic criteria. Diagnostic confirmation will be done by consultant psychiatrist of the institution. Participant information sheet will be given and written informed consent shall be received from willing individuals having insight and from the legally authorized representative if the individual lacks insight. Detailed case-taking will be done on the case recording format. Challenging behavior shall be assessed using BPI-S. Those individuals whose score ≥ 6 for at least one item under the subscales SIB/DAB or a score of 4 for at least one item from SB subscale shall be enrolled for the study. Assessment of BASAL MR- PART B will be done at baseline for the enrolled subjects. Totality of symptoms will be erected and repertorisation will be done with appropriate repertory as per the requirement of the case. Final selection of the medicine will be done after comparing it with Homoeopathic Materia Medica. IHM shall be prescribed in suitable potency based on the susceptibility of the patient at baseline. The dose and repetition of medicine in the follow up visits will be done based on Homoeopathic principles. If there is no change at all, the case shall be retaken, and another appropriate medicine will be prescribed. If any acute complaint arises, appropriate medicine will be administered based on the acute totality and 9 shall be recorded in the follow-up sheets. Telephonic consultation will be done as per the need of the patient or if there are no follow-up visits for 2 months. If there is no follow up for 3 consecutive months, the case is considered as drop out. If drop out cases returning for treatment will be given regular treatment but will not include in the study further. Those who are willingly withdrawn from the study will also be given regular treatment but will not consider them for the purpose of study analysis. Post-trial care shall be given in the regular OPDs of NHRIMH.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants who are diagnosed with Intellectual Disability as per DSM 5 criteria.
  • Participants having score ≥ 6 for at least one item under the subscales SIB/DAB or a score of 4 for at least one item from SB subscale in BPI-S scale.

排除标准

  • ID patients with psychosis and severe depression
  • Participant with any serious systemic diseases.
  • Pregnant and lactating women.

结局指标

主要结局

Assessment of reduction in the severity of Challenging behavior after the administration of individualized homoeopathic medicine using BPI-S scale

时间窗: once in 3 months for 1 year

次要结局

  • Assessment of reduction in behavioral problems after the administration of Individualized Homoeopathic Medicine using PART B of BASAL MR(Baseline and after the completion of the study)

研究者

发起方
Nisma K U
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Nisma K U

National Homoeopathy Research Institute in Mental Health, sachivothamapuram P O, kurichy , Kottayam

研究点 (1)

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