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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01488825
Other study ID # NMP-0090-YR
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2011
Last updated December 7, 2011
Start date January 2005
Est. completion date June 2006

Study information

Verified date December 2011
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date June 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- aged between 18 to 60 years

- more than 5 but fewer than 15 headache episodes per month

- headache intensity moderate to severe

Exclusion Criteria:

- Patients on anti-psychotic, antidepressant or any prophylactic medication

- pregnancy

- Taking psychotherapy or any other alternative medicine

- migraine headache more than 1 day a month

- pain disorder, psychiatric or medical disorder requiring immediate treatment,

- headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Yoga Therapy
Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.

Locations

Country Name City State
India Pain Clinic, NMP Medical Research Institute Jaipur Rajasthan

Sponsors (1)

Lead Sponsor Collaborator
NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of headache 3 Months No
Secondary Duration of Headache 3 months No
Secondary Severity of headache 3 Months No
Secondary Analgesic consumption 3 Months No
Secondary Anxiety levels 3 months No
Secondary Depression 3 months No
Secondary Stress 3 months No