Usefulness of Shirodhara for Insomnia - Full Text View

Sponsored by:	Southern California University of Health Sciences
Information provided by:	Southern California University of Health Sciences
ClinicalTrials.gov Identifier:	NCT00606658

Purpose

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

Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:

Insomnia Severity Index [ Time Frame: Baseline, end of five days and end of 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HD-16 Quality of Life Scale [ Time Frame: Baseline, end of 5 days and 14 days ] [ Designated as safety issue: No ]

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)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606658

Locations

United States, California
Southern California University of Health Sciences
Whittier, California, United States, 90604

Sponsors and Collaborators

Southern California University of Health Sciences

Investigators

Principal Investigator:

Sivarama P Vinjamury, MAOM

Southern California University of Health Sciences

More Information

Additional Information:

Visit Southern California University of Health Sciences Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southern California University of Health Sciences ( Sivarama P Vinjamury )
Study ID Numbers:	SCU-07-VINJ002
Study First Received:	January 21, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00606658 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Southern California University of Health Sciences:

Insomnia
Ayurveda
Shirodhara
Quality of Life

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Quality of Life

Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 03, 2009