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Usefulness of Shirodhara for Insomnia

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Procedure: Shirodhara Oil Treatment Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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United States, California
Southern California University of Health Sciences
Whittier, California, United States, 90604
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
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Principal Investigator: Sivarama P Vinjamury, MAOM Southern California University of Health Sciences
More Information
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Additional Information:

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Responsible Party: Sivarama Vinjamury, Associate Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT00606658    
Other Study ID Numbers: SCU-07-VINJ002
First Posted: February 4, 2008    Key Record Dates
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:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders