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Completed

NCT Number: NCT04113512

Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache

To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.

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Key information

Conditions

Chronic Tension-Type Headache

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yoga Bhavan

Jaipur, Rajasthan, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Jalaneti

Other

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

Primary outcomes

  1. Headache Frequency

    Time frame: Change from baseline to 6 weeks

    Number of days with headache was assessed using headache diary

Secondary outcomes

  1. Headache severity

    Time frame: Change from baseline to 6 weeks

    Mean pain intensity of tension-type headache measured using Visual Analogue Scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain

  2. Duration of Headache

    Time frame: Change from baseline to 6 weeks

    Duration of each headache attack (hours per day)

  3. Headache disability

    Time frame: Change from baseline to 6 weeks

    Disability caused by headache was measure using Headache Impact Test (HIT-6).

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Collaborators

  • University of Rajasthan
  • Yog-Kulam

Registry information

Official study title

Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache: Randomised Waitlist Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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