NCT00842881

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

February 11, 2009

Last Update Submit

September 23, 2009

Conditions

Primary Dysmenorrhea

Keywords

Healingstone

Outcome Measures

Primary Outcomes (1)

  • 10cm VAS of pain(Dysmenorrhea)

    5months

Secondary Outcomes (1)

  • quality of life (SF-36)

    7months

Study Arms (2)

a

NO INTERVENTION

healingstone

Device: Healingstone navel belt

b

NO INTERVENTION

stone powder

Device: Healingstone navel belt

Interventions

Healingstone navel beltDEVICE

6\~8hours/day for 3months

Also known as: Serial Number : HS-402
ab

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • EungGi Min, MD

    DongGuk University Hosipital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

September 24, 2009

Record last verified: 2009-09