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CTRI Number  CTRI/2017/10/010074 [Registered on: 12/10/2017] Trial Registered Retrospectively
Last Modified On: 08/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Ayurveda and Yoga for Migraine 
Scientific Title of Study   Use of an Integrated approach of Yoga therapy and Ayurveda in the management of Migraine  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  H R Nagendra 
Designation  Professor 
Affiliation  S-VYASA University 
Address  division of yoga and life sciences university campus,Prashanthi Kutiram, Kallabalu post, Jigani hobli, Anekal Talluk, Bengaluru-560105
City office # 19, ‘Eknath Bhavan’, Gavipuram Circle, Kempe Gowda Nagar, Bengaluru – 560 019, INDIA
Bangalore
KARNATAKA
560105
India 
Phone  9880609595  
Fax    
Email  hrnagendra1943@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vasudha M Sharma 
Designation  Doctoral Scholar 
Affiliation  S-VYASA University 
Address  Division of Yoga and Life sciences, University campus,Prashanthi Kutiram, Kallabalu post, Jigani hobli, Anekal Talluk, Bengaluru
SVYASA university kallabalu post Jigani hobli Anekal taluk Bengaluru
Bangalore
KARNATAKA
560105
India 
Phone  9880609595  
Fax    
Email  vasudhamsharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  H R Nagendra 
Designation  Professor 
Affiliation  S-VYASA University 
Address  Division of Yoga and Life sciences Prashanthi Kutiram, Kallabalu post, Jigani hobli, Anekal Talluk, Bengaluru

Bangalore
KARNATAKA
560102
India 
Phone  9880609595  
Fax    
Email  hrnagendra1943@gmail.com  
 
Source of Monetary or Material Support  
Swami Vivekananda Yoga Anusandhana Samsthana, A Deemed to be University.  
 
Primary Sponsor  
Name  SVYASA University 
Address  Kallubalu post, Jigani Hobli, Anekal Talluk, Bengaluru 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vasudha M Sharma  S-VYASA University Teaching Hospital  Dept of Yoga and life sciences, Jigani, Anekal Talluk, Bengaluru
Bangalore
KARNATAKA 
9880609595

vasudhamsharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S-VYASA Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Allopathic Medications  NSAIDS 
Intervention  Yoga Therapy and AYurveda  Traditional Ayurveda including Virechana followed by Yoga therapy and Shamanoushada 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  46.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
EMG, HRV, MIDAS  1-30-90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived Stress Scale, Symptom check list, Comprehensive Headache related Quality of LIfe Questionnaire
Prakruthi Analysis
 
PSS, SCL,
1-30-90 days
CHQQ
1-90 days
Prakriti Analysis
Day 1 only 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   23/01/2015 
Date of Study Completion (India) 12/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/08/2017 
Estimated Duration of Trial   Years="2"
Months="7"
Days="13" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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.  

 
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