NCT00606658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2008

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

January 21, 2008

Last Update Submit

September 18, 2012

Conditions

Insomnia

Keywords

InsomniaAyurvedaShirodharaQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index

    Baseline, end of five days and end of 14 days

Secondary Outcomes (1)

  • HD-16 Quality of Life Scale

    Baseline, end of 5 days and 14 days

Study Arms (1)

Oil dripping therapy

OTHER

Single Arm

Procedure: Shirodhara Oil Treatment

Interventions

Shirodhara Oil TreatmentPROCEDURE

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

Oil dripping therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Sivarama P Vinjamury, MAOM

    Southern California University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 4, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

US(1)