Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache
1 other identifier
interventional
98
1 country
1
Brief Summary
To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedOctober 2, 2019
October 1, 2019
4 months
October 1, 2019
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Headache Frequency
Number of days with headache was assessed using headache diary
Change from baseline to 6 weeks
Secondary Outcomes (3)
Headache severity
Change from baseline to 6 weeks
Duration of Headache
Change from baseline to 6 weeks
Headache disability
Change from baseline to 6 weeks
Study Arms (2)
Yoga Nasal Irrigation Group
EXPERIMENTALSaline nasal irrigation using neti pot was practiced.
Wait list Control group
NO INTERVENTIONGroup was given usual pain medication. After trial period, they were offered the intervention.
Interventions
Sterilised and lukewarm isotonic salt water using neti pot was poured into one nostril, so that it leaves through the other. The procedure is then repeated on the other side, and the nose is dried by bending forward and by rapid yoga breathing
Eligibility Criteria
You may qualify if:
- Meeting the diagnostic criteria of chronic tension type headache as per International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3 beta criteria)
- Aged 18-60 years;
- Ability of understand and completing the headache dairy;
- Volunteering to the study
- Provide written informed consent.
You may not qualify if:
- Not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month.
- Taking any prophylactic headache medication or complementary and alternative medicine in last 3 month;
- Secondary Headaches
- In pregnancy, lactation, or planning to be pregnant in 6 months
- Having nose bleeding disorders or recurrent infections;
- Psychiatric diagnosis or medication history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NMP Medical Research Institutelead
- University of Rajasthancollaborator
- Yog-Kulamcollaborator
Study Sites (1)
Yoga Bhavan
Jaipur, Rajasthan, India
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Sharma, PhD
Yog-Kulam
- STUDY CHAIR
Jaydeep Joshi
Yog-Kulam
- STUDY CHAIR
Placheril John, PhD
University of Rajasthan, India
- STUDY DIRECTOR
Shekhar Sharma
NMP Medical Research Institute, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 2, 2019
Study Start
March 15, 2019
Primary Completion
June 30, 2019
Study Completion
July 26, 2019
Last Updated
October 2, 2019
Record last verified: 2019-10