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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Healingstone Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00842881
First received: February 11, 2009
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Primary Dysmenorrhea
Device: Healingstone navel belt
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

Further study details as provided by Healingstone Co., Ltd.:

Primary Outcome Measures:
  • 10cm VAS of pain(Dysmenorrhea) [ Time Frame: 5months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life (SF-36) [ Time Frame: 7months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: August 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: a
healingstone
Device: Healingstone navel belt
6~8hours/day for 3months
Other Names:
  • Healingstone navel belt
  • Serial Number : HS-402
No Intervention: b
stone powder
Device: Healingstone navel belt
6~8hours/day for 3months
Other Names:
  • Healingstone navel belt
  • Serial Number : HS-402

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842881

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

No publications provided

Responsible Party: Mijin Park / Manager, Healingstone Co., Ltd.
ClinicalTrials.gov Identifier: NCT00842881     History of Changes
Other Study ID Numbers: HS-01-001
Study First Received: February 11, 2009
Last Updated: September 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Healingstone Co., Ltd.:
Healingstone

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

ClinicalTrials.gov processed this record on November 24, 2014