Usefulness of Shirodhara for Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606658
• Other study ID #: SCU-07-VINJ002
• Status: Completed
• Phase: Phase 0
• First received: January 21, 2008
• Last updated: September 18, 2012
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2012
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Procedure:
• Shirodhara Oil Treatment
Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.

Locations

Country	Name	City	State
United States	Southern California University of Health Sciences	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index		Baseline, end of five days and end of 14 days	No
Secondary	HD-16 Quality of Life Scale		Baseline, end of 5 days and 14 days	No

External Links

•   Visit Southern California University of Health Sciences Website