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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series|
- Insomnia Severity Index [ Time Frame: Baseline, end of five days and end of 14 days ] [ Designated as safety issue: No ]
- HD-16 Quality of Life Scale [ Time Frame: Baseline, end of 5 days and 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Oil dripping therapy
Procedure: Shirodhara Oil Treatment
Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606658
|United States, California|
|Southern California University of Health Sciences|
|Whittier, California, United States, 90604|
|Principal Investigator:||Sivarama P Vinjamury, MAOM||Southern California University of Health Sciences|