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Usefulness of Shirodhara for Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606658
First Posted: February 4, 2008
Last Update Posted: September 20, 2012
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.
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences
  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 Early Phase 1

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

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

Primary Outcome Measures:
  • Insomnia Severity Index [ Time Frame: Baseline, end of five days and end of 14 days ]

Secondary Outcome Measures:
  • HD-16 Quality of Life Scale [ Time Frame: Baseline, end of 5 days and 14 days ]

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)
Arms Assigned Interventions
Oil dripping therapy
Single Arm
Procedure: Shirodhara Oil Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Sivarama Vinjamury, Associate Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT00606658     History of Changes
Other Study ID Numbers: SCU-07-VINJ002
First Submitted: January 21, 2008
First Posted: February 4, 2008
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by Sivarama Vinjamury, Southern California University of Health Sciences:
Insomnia
Ayurveda
Shirodhara
Quality of Life

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders