Usefulness of Shirodhara for Insomnia

Southern California University of Health Sciences

Status and phase: Completed; Early Phase 1

Conditions: Insomnia

Treatments: Procedure: Shirodhara Oil Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00606658

SCU-07-VINJ002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Oil dripping therapy

Other group

Description:

Single Arm

Treatment:

Procedure: Shirodhara Oil Treatment