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Usefulness of Shirodhara for Insomnia

NCT ID: NCT00606658

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

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.

Conditions

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Insomnia

Keywords

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Insomnia Ayurveda Shirodhara Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oil dripping therapy

Single Arm

Group Type OTHER

Shirodhara Oil Treatment

Intervention Type PROCEDURE

Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.

Interventions

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Shirodhara Oil Treatment

Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern California University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sivarama Vinjamury

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sivarama P Vinjamury, MAOM

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences

Locations

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Southern California University of Health Sciences

Whittier, California, United States

Site Status

Countries

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United States

Related Links

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http://www.scuhs.edu

Visit Southern California University of Health Sciences Website

Other Identifiers

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SCU-07-VINJ002

Identifier Type: -

Identifier Source: org_study_id