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临床试验/CTRI/2020/10/028621
CTRI/2020/10/028621招募中2/3 期

Individualized homoeopathic medicines in treatment of chronic migraine: Double-blind, randomized, placebo-controlled, pilot trial

The Calcutta Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月26日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Monthly migraine days (MMD)

研究概览

简要总结

Migraine is defined as ‘headache occurring on ≥15 days/month for > 3 months with features of migraine on ≥8 days/months. Presenting symptoms include throbbing pain either one-sided (usually) or bilateral, aggravated on least movement, associated with nausea, dizziness, extreme sensitivity to lights, noises, smell, lack of appetite, bowel disturbances and visual or sensory aura.  It is included among top 40 conditions, which cause worldwide disability and it produces 3.63 times greater disability. Recent studies showed about 8.4% of Indian population is suffering from chronic migraine. There was no study conducted in past 10 yrs in homoeopathy on migraine. In this double-blind, randomized, placebo-controlled trial at The Calcutta Homoeopathic Medical College and Hospital, 60 patients suffering from chronic migraine will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical looking placebo (control; n=30). We aim to examine whether there are any differences in outcomes between these two groups over 3 months of intervention. Monthly migraine days (MMD) scores, Migraine Disability Assessment Test (MIDAS) scores and EQ-5D-5L scores will be used as the primary and secondary outcome measures respectively, measured at baeline and every month up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from chronic migraine, that is, headache on 15 or more days/month for more than 3 months, with a feature of migraine headache on at least 8 days/month (ICD-10-CM Code G43.709)
  • Patients of 18-65 years of age and of either sex
  • Patients who have not taken any treatment since at least 2 weeks for migraine
  • Literate patients; can read Bengali and/or English
  • Providing written informed consent to participate in the trial.

排除标准

  • Patients suffering from the complications of migraine
  • Patients who are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetic, or oestrogen during 2 weeks prior to enrolment in the study
  • Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life
  • Patients who are too sick for consultation
  • Pregnant and puerperal women, and lactating mothers
  • Substance abuse and/or dependence
  • Self-reported immune-compromised state
  • Undergoing homoeopathic treatment for any chronic disease within last 6 months.

结局指标

主要结局

Monthly migraine days (MMD)

时间窗: At baseline, every month, up to 3 months

次要结局

  • Migraine Disability Assessment Test (MIDAS) scores(At baseline, every month, up to 3 months)
  • EQ-5D-5L scores(At baseline, every month, up to 3 months)

研究者

发起方
The Calcutta Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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