Usefulness of Shirodhara for Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00606658
First received: January 21, 2008
Last updated: September 18, 2012
Last verified: September 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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
Study First Received: January 21, 2008
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014