Usefulness of Shirodhara for Insomnia

• ClinicalTrials.gov Identifier: NCT00606658
• Recruitment Status: Completed
• First Posted: February 4, 2008
• Last Update Posted: September 20, 2012
• Sponsor: Southern California University of Health Sciences
• Information provided by (Responsible Party): Sivarama Vinjamury, Southern California University of Health Sciences

Tracking Information

• First Submitted Date: January 21, 2008
• First Posted Date: February 4, 2008
• Last Update Posted Date: September 20, 2012
• Study Start Date: January 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 21, 2008): Insomnia Severity Index [ Time Frame: Baseline, end of five days and end of 14 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 21, 2008): HD-16 Quality of Life Scale [ Time Frame: Baseline, end of 5 days and 14 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Usefulness of Shirodhara for Insomnia
• Official Title: Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
• Brief 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Insomnia

Intervention

Procedure: Shirodhara Oil Treatment

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

Study Arms

Oil dripping therapy

Single Arm

Intervention: Procedure: Shirodhara Oil Treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2008): 10
• Original Estimated Enrollment (submitted: January 21, 2008): 5
• Actual Study Completion Date: September 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00606658
• Other Study ID Numbers: SCU-07-VINJ002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sivarama Vinjamury, Southern California University of Health Sciences
• Study Sponsor: Southern California University of Health Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sivarama P Vinjamury, MAOM; Southern California University of Health Sciences

• PRS Account: Southern California University of Health Sciences
• Verification Date: September 2012