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Completed

NCT Number: NCT00606658

Usefulness of Shirodhara for Insomnia

This pilot study will attempt to test the effects of this non-invasive procedure on a small sample of insomnia patients and also determine the feasibility of recruiting and retaining participants during the trial for such treatments in the United States.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Southern California University of Health Sciences

Whittier, California, 90604, United States

About this study

A prospective case series design will be adopted. Due to the small sample size and the preliminary nature of the study, a single case study or case series are classified under Observational Descriptive Studies. The investigators will seek local Institutional Review Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled into the study. Successful enrollment is based on strict inclusion and exclusion criteria. Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform Shirodhara. Each participant will be treated for 40 minutes for five consecutive days. Outcome measures data will be collected at baseline, third day and fifth day and a week after the treatment is over. Additionally, demographic data will be collected at baseline as well. Participants will be asked to record any adverse events or side effects they observe during the study period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 of either sex
  • Duration of insomnia at least one year
  • Willing to sign an informed consent
  • A score of minimum 14 on the Insomnia severity index

Exclusion criteria

  • Comorbidities such as Depression or any other psychological conditions that require medications
  • Currently on prescription medication for insomnia
  • Serious medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or any other acute condition that disturbs sleep and requires waking up in the middle of the night
  • Participants unwilling to comply with the protocol
  • Anyone who is in litigation or receiving disability, workers' compensation benefits

Treatment and study plan

Shirodhara Oil Treatment

Procedure

Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Baseline, end of five days and end of 14 days

Secondary outcomes

  1. HD-16 Quality of Life Scale

    Time frame: Baseline, end of 5 days and 14 days

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Registry information

Official study title

Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 4, 2008
Registry last updated
Sep 20, 2012

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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