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临床试验/CTRI/2021/07/034981
CTRI/2021/07/034981尚未招募3 期

Development and validation of integrated yoga therapy module for patients suffering with Migraine.

Dr Girish Baburao Kulkarni1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年7月19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
10
试验地点
1
主要终点
To develop an integrated yoga module for patients with migraine and study its feasibility in this population.

研究概览

简要总结

Migraine is known to be one of the commonest primary headache disorders affecting 13% of the population worldwide.  Although pharmacological interventions have been used to reduce symptoms and frequency of attacks of migraine overuse of these medications may increase headache progression. Failing to achieve optimal control over migraine pain or unacceptable medication side effects might have led to the use of complementary and alternative medicine (CAM) either alone or in combination with drugs.

Although several studies have shown the beneficial effects of yoga therapy in migraines a validated yoga module has not been used. Therefore we propose to develop and validate an integrated yoga  module for management and prophylaxis of migraine as an adjunct and study its feasibility and acceptability. Also, we would like to assess if yoga can be practiced along with routine medications.

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 45.00 Year(s)(—)
性别
All

入选标准

  • History of headache for more than 6 months Patients having migraine with or without aura with a frequency of 2 to 8 attacks per month.
  • Have had migraine for at least 1 year before participating in the study and before the age of
  • Migraine diagnosis according to The International Classification of Headache Disorders criteria confirmed by a Neurologist.
  • Willing to follow medical and lifestyle advice Minimum education with the ability to read and write.

排除标准

  • Subjects diagnosed with any syndromal psychiatric disorder or suicidality.
  • Major medical illness under treatment Women having migraine related to menstruation Severe headache requiring acute intervention as assessed by the neurologist Interval headaches not distinguishable from migraine Medication-overuse headache Use of daily migraine prophylaxis in the 12 weeks prior to the study Regular yoga practice past 3 months (three or more times per week prior to the study) Earlier regular practice of relaxation Use of any other form of alternative medicine Any medical comorbidity which is an exclusion for practicing yoga Pregnancy Clotting disorders Breastfeeding.

结局指标

主要结局

To develop an integrated yoga module for patients with migraine and study its feasibility in this population.

时间窗: Baseline, 5 days and 1 month.

次要结局

  • NA(NA)

研究者

发起方
Dr Girish Baburao Kulkarni
申办方类型
Other [CCRYN Delhi]

研究点 (1)

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