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

NCT ID: NCT00842881

Last Updated: 2009-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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a

healingstone

Group Type NO_INTERVENTION

Healingstone navel belt

Intervention Type DEVICE

6\~8hours/day for 3months

b

stone powder

Group Type NO_INTERVENTION

Healingstone navel belt

Intervention Type DEVICE

6\~8hours/day for 3months

Interventions

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Healingstone navel belt

6\~8hours/day for 3months

Intervention Type DEVICE

Other Intervention Names

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Serial Number : HS-402

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Healingstone Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Healingstone Co., Ltd.

Principal Investigators

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EungGi Min, MD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University Hosipital

Other Identifiers

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HS-01-001

Identifier Type: -

Identifier Source: org_study_id

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