NCT00606658

Usefulness of Shirodhara for Insomnia

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Southern California University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
PROCEDURE	Shirodhara Oil Treatment	Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-02-04
• Last updated: 2012-09-20

Locations

1 site across 1 country: United States