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Usefulness of Shirodhara for Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606658
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : September 20, 2012
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 4, 2008
Last Update Posted Date September 20, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
Insomnia Severity Index [ Time Frame: Baseline, end of five days and end of 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
HD-16 Quality of Life Scale [ Time Frame: Baseline, end of 5 days and 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usefulness of Shirodhara for Insomnia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE Procedure: Shirodhara Oil Treatment
Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
Study Arms  ICMJE Oil dripping therapy
Single Arm
Intervention: Procedure: Shirodhara Oil Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2008)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2008)
5
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606658
Other Study ID Numbers  ICMJE SCU-07-VINJ002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sivarama Vinjamury, Southern California University of Health Sciences
Study Sponsor  ICMJE Southern California University of Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sivarama P Vinjamury, MAOM Southern California University of Health Sciences
PRS Account Southern California University of Health Sciences
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP