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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00842881
Recruitment Status : Unknown
Verified September 2009 by Healingstone Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : February 12, 2009
Last Update Posted : September 24, 2009
Sponsor:
Information provided by:
Healingstone Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Device: Healingstone navel belt Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
Study Start Date : August 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: a
healingstone
Device: Healingstone navel belt
6~8hours/day for 3months
Other Name: Serial Number : HS-402
No Intervention: b
stone powder
Device: Healingstone navel belt
6~8hours/day for 3months
Other Name: Serial Number : HS-402



Primary Outcome Measures :
  1. 10cm VAS of pain(Dysmenorrhea) [ Time Frame: 5months ]

Secondary Outcome Measures :
  1. quality of life (SF-36) [ Time Frame: 7months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842881


Sponsors and Collaborators
Healingstone Co., Ltd.
Investigators
Principal Investigator: EungGi Min, MD DongGuk University Hosipital

Additional Information:
Responsible Party: Mijin Park / Manager, Healingstone Co., Ltd.
ClinicalTrials.gov Identifier: NCT00842881     History of Changes
Other Study ID Numbers: HS-01-001
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by Healingstone Co., Ltd.:
Healingstone

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms