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Sponsored by: |
Southern California University of Health Sciences |
Information provided by: | Southern California University of Health Sciences |
ClinicalTrials.gov Identifier: | NCT00606658 |
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.
Condition | Intervention | Phase |
Insomnia |
Procedure: Shirodhara Oil Treatment |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series |
Enrollment: | 10 |
Study Start Date: | January 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Southern California University of Health Sciences | |||||
Whittier, California, United States, 90604 |
Southern California University of Health Sciences |
Principal Investigator: | Sivarama P Vinjamury, MAOM | Southern California University of Health Sciences |
Visit Southern California University of Health Sciences Website 
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Responsible Party: | Southern California University of Health Sciences ( Sivarama P Vinjamury ) |
Study ID Numbers: | SCU-07-VINJ002 |
First Received: | January 21, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00606658 |
Health Authority: | United States: Institutional Review Board |
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