Usefulness of Shirodhara for Insomnia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series

Conditions
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Insomnia

Intervention / Treatment
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* Procedure: Shirodhara Oil Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oil dripping therapy<br>Single Arm | Procedure: Shirodhara Oil Treatment<br>* Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index |  | Baseline, end of five days and end of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HD-16 Quality of Life Scale |  | Baseline, end of 5 days and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Ayurveda, Shirodhara, Quality of Life