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临床试验/CTRI/2025/11/097134
CTRI/2025/11/097134尚未招募2 期

The effectiveness of individualized homoeopathic treatment on chronic migraine associated with stress and anxiety using MIDAS scale : an open label, prospective, clinical study

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
MIDAS scale

研究概览

简要总结

This clinical study will evaluate the effectiveness of individualized homoeopathic treatment in individuals diagnosed with chronic migraine (ICD-11 code: 8A80.2) and emotional symptoms such as anxiety and depression. The study will span 1 year and 6 months, with monthly follow-ups. Evaluations will be conducted at baseline, 3rd month, and 6th month using standardized tools: MIDAS (Migraine Disability Assessment), PSS (Perceived Stress Scale), and BAI (Beck Anxiety Inventory). Participants will be selected based on defined inclusion and exclusion criteria, and informed consent will be obtained prior to enrollment.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Participants who are diagnosed with chronic migraine according to ICHD – 3 criteria.
  • Participants diagnosed with chronic migraine with stress or anxiety or both.
  • Participants of age between 18 to 50 years of age.
  • Participants who are willing to participate with informed consent in the study.
  • Participants who can able to understand and communicate.

排除标准

  • Participants who are diagnosed with an unstable mental or psychiatric illness.
  • Participants suffering from serious systematic disorders or life-threatening diseases.
  • Pregnant or lactating women.
  • Migraine due to estrogen based hormonal therapeutics like oral contraceptive pills (OCPs), hormonal replacement therapy (HRT).
  • Immune-compromised diseased conditions.

结局指标

主要结局

MIDAS scale

时间窗: Base line, 3rd month, 6th month.

次要结局

  • PSS-14(BAI-21)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR BONELA SIRISHA

National Institute of Homoeopathy

研究点 (1)

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