Usefulness of Shirodhara for Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Shirodhara Oil Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Ayurveda, Shirodhara, Quality of Life
Eligibility 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
Sites / Locations
- Southern California University of Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Oil dripping therapy
Arm Description
Single Arm
Outcomes
Primary Outcome Measures
Insomnia Severity Index
Secondary Outcome Measures
HD-16 Quality of Life Scale
Full Information
NCT ID
NCT00606658
First Posted
January 21, 2008
Last Updated
September 18, 2012
Sponsor
Southern California University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00606658
Brief Title
Usefulness of Shirodhara for Insomnia
Official Title
Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Ayurveda, Shirodhara, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oil dripping therapy
Arm Type
Other
Arm Description
Single Arm
Intervention Type
Procedure
Intervention Name(s)
Shirodhara Oil Treatment
Intervention Description
Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Time Frame
Baseline, end of five days and end of 14 days
Secondary Outcome Measure Information:
Title
HD-16 Quality of Life Scale
Time Frame
Baseline, end of 5 days and 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivarama P Vinjamury, MAOM
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.scuhs.edu
Description
Visit Southern California University of Health Sciences Website
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