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临床试验/CTRI/2017/10/010074
CTRI/2017/10/010074已完成2/3 期

Use of an Integrated approach of Yoga therapy and Ayurveda in the management of Migraine

SVYASA University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月23日最近更新:
适应症

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
EMG, HRV, MIDAS

研究概览

简要总结

Objectives: To study the influence of Ayurveda and Yoga in patients suffering from Migraine headache

Methodology:

Subjects: 60 subjects (both genders) diagnosed with Migraine headache based on the International Headache Society’s diagnostic criteria were recruited.

Intervention: 30 of them who chose to undergo Ayurveda and Yoga treatment for Migraine were recruited to experimental Group, while the other 30 who were on standard allopathy treatment were selected under control group.

Assessments: The subjects were assessed on Day 1, Day 30 and Day 90. The assessments included Surface EMG recorded from the forehead, Heart rate Variability, Respiratory rate, MIDAS, Headache related Quality of Life Questionnaire, Perceived Stress Scale and Prakruthi Analysis.

Intervention: An integrated Approach of Ayurveda followed by Yoga Therapy was given for 90 days. Ayurveda included Snehapana with Kalyanaka gritha for 3-5 days, Abhyanga and Sweda for 3 days followed by Virechana. This was proceeded by Oral medication (Pathyaksha Dhatryadi Kasha yam, Avipathi Choorna, and external application of Kachoradhi Choorna to the forehead) with Yoga Therapy for the period of 90 days. Customised Yoga Therapy for Migraine included Breathing exercises, Loosening exercises, Asanas, Pranayama, Relaxation and Chanting.

Results: The data were analysed using Repeated Measures ANOVA with post-hoc analysis doing multiple comparisons between the mean values of individual variables.

Following 30 and 90 days of Ayurveda and Yoga therapy compared to Day 1 values, there was a significant reduction in the Migraine related disability scores (MIDAS) (p<.001, for both comparisons), Perceived Stress Scale scores (p<.01, p<.001, respectively), Autonomic arousal measured by Heart Rate Variability (Decreased LF component (p<.05), increased HF (p<.05) and decreased LF/HF ratio (p<.01)), and EMG amplitude (p<.05). There was also a significant improvement in the Physical, Mental and Social domains of Headache related Quality of Life( p<.01). The Control Group showed no change in the Quality of life (p<.05, for all three domains). There was no change in MIDAS scores, Perceived Stress scores, Autonomic variables as well as EMG amplitude (p>.05 for all comparisons).

Conclusion: Integrated Ayurveda and Yoga intervention has shown to reduce the frequency and intensity of headache, reduce Migraine related disability, lower medication scores, Reduce perceived stress and Improve quality of life in patients suffering from Migraine. Also, there was a decreased amplitude in EMG during frowning and an increase in the High frequency component and reduction in the low frequency component of HRV suggesting reduced physiological arousal and better relaxation. The control group showed No changes in most of the variables measured, while their quality of life has worsened significantly.

The present study demonstrated the therapeutic benefits of an integrated Ayurveda and Yoga based intervention in in the management of Migraine Headache.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 46.00 Year(s)(—)
性别
All

入选标准

  • History of headache for more than one year 5 or more attacks of headache in three months Willingness to participate in the trial and follow diet restrictions Complete headache dairy Medicines for 90 days.

排除标准

  • Subjects with primary psychiatric disorders major medical illness pregnancy pure menstrual migraine menopausal women subjects who were on ayurveda or yoga for the past six months.

结局指标

主要结局

EMG, HRV, MIDAS

时间窗: 1-30-90 days

次要结局

  • Perceived Stress Scale, Symptom check list, Comprehensive Headache related Quality of LIfe Questionnaire(Prakruthi Analysis)

研究者

发起方
SVYASA University
申办方类型
Research institution and hospital

研究点 (1)

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