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NCT00842881 Clinical Trial

A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

— Healingstone  

Official title:
Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00842881
Other study ID # HS-01-001
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received February 11, 2009
Last updated September 23, 2009
Start date August 2008
Est. completion date September 2009

Study information
Verified date September 2009
Source Healingstone Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 102
Est. completion date September 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 45 Years
Eligibility Inclusion Criteria:

- Age : female adults aged 15~45 years

- Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual.

- Subjects should have 21~42 days menstrual cycle.

- menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug.

- Subjects must have no Serious internal medicine.

- Subjects must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

- Subject that oral contraceptive taken within 3 months

- Pregnancy or lactation.

- Subject have contraceptive that secrete hormone.

- Secondary dysmenorrhea

- pelvis inflammatory disease patient

- Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Healingstone navel belt
6~8hours/day for 3months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Healingstone Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary 10cm VAS of pain(Dysmenorrhea) 5months No
Secondary quality of life (SF-36) 7months Yes
See also
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