- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606658
Usefulness of Shirodhara for Insomnia
September 18, 2012 updated by: Sivarama Vinjamury, Southern California University of Health Sciences
Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Whittier, California, United States, 90604
- Southern California University of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Oil dripping therapy
Single Arm
|
Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insomnia Severity Index
Time Frame: Baseline, end of five days and end of 14 days
|
Baseline, end of five days and end of 14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HD-16 Quality of Life Scale
Time Frame: Baseline, end of 5 days and 14 days
|
Baseline, end of 5 days and 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sivarama P Vinjamury, MAOM, Southern California University of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 21, 2008
First Submitted That Met QC Criteria
January 21, 2008
First Posted (Estimate)
February 4, 2008
Study Record Updates
Last Update Posted (Estimate)
September 20, 2012
Last Update Submitted That Met QC Criteria
September 18, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCU-07-VINJ002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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