Completed

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

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What is being tested

Shirodhara Oil Treatment

Procedure
Who is being recruted

Mental Disorders+3

+ Sleep Initiation and Maintenance Disorders

+ Nervous System Diseases

From 18 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: January 2008
See protocol details

Summary

Principal SponsorSouthern California University of Health Sciences
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2008

Actual date on which the first participant was enrolled.

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 TitleUsefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
NCT00606658
Principal SponsorSouthern California University of Health Sciences
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

4 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Single Arm

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Southern California University of Health Sciences

Whittier, United StatesOpen Southern California University of Health Sciences in Google Maps
CompletedOne Study Center