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

Healingstone Co., Ltd.

Status and phase

Unknown

Phase 3

Conditions

Primary Dysmenorrhea

Treatments

Device: Healingstone navel belt

Study type

Interventional

Funder types

Industry

Identifiers

HS-01-001

Details and patient eligibility

About

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

Enrollment

102 estimated patients

Sex

Female

Ages

15 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.