Usefulness of Shirodhara for Insomnia

Early Phase 1

Completed

• Conditions: Insomnia
• Interventions: Procedure: Shirodhara Oil Treatment

• Registration Number: NCT00606658
• Lead Sponsor: Southern California University of Health Sciences

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-01-21
• Study First Posted: 2008-02-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oil dripping therapy	Shirodhara Oil Treatment	Single Arm

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Baseline, end of five days and end of 14 days

Secondary Outcome Measures

Name	Time	Method
HD-16 Quality of Life Scale	Baseline, end of 5 days and 14 days

Trial Locations

Locations (1)

Southern California University of Health Sciences; 🇺🇸 Whittier, California, United States