Primary DysmenorrheaPhase 3HealingstoneNCT00842881
A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
A Phase 3 study testing Healingstone navel belt in people with Primary Dysmenorrhea, run by Healingstone Co., Ltd..
Trial summary
The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Healingstone navel belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Healingstone navel belt
- Keywords
- Healingstone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healingstone navel beltDevice
Also called Serial Number : HS-402
6~8hours/day for 3months
| Study group | Role | What they receive |
|---|---|---|
| a | No intervention | healingstone Receives: Device: Healingstone navel belt |
| b | No intervention | stone powder Receives: Device: Healingstone navel belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
10cm VAS of pain(Dysmenorrhea)
Measured: 5months
Secondary outcomes (1)
quality of life (SF-36)
Measured: 7months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healingstone Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- EungGi Min, MD, Principal investigator, DongGuk University Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842881
- Sponsor's protocol ID
- HS-01-001
- Acronym
- Healingstone
- Status last verified
- Sep 2009
- First submitted
- 11 Feb 2009
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00842881
- Acronym / sponsor ID
- Healingstone / HS-01-001
- Conditions
- Primary Dysmenorrhea
- Keywords
- Healingstone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Healingstone Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | No intervention | Device: Healingstone navel belthealingstone |
| b | No intervention | Device: Healingstone navel beltstone powder |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Subject that oral contraceptive taken within 3 months
- Pregnancy or lactation.
- Subject have contraceptive that secrete hormone.
- Secondary dysmenorrhea
- pelvis inflammatory disease patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healingstone navel beltAlso: Serial Number : HS-4026~8hours/day for 3months | Device | a, b |
Primary outcome
10cm VAS of pain(Dysmenorrhea)
Time frame: 5months
1 secondary outcome
quality of life (SF-36)
Time frame: 7months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EungGi Min, MD principal investigator
DongGuk University Hosipital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Healingstone navel belt in people with Primary Dysmenorrhea, run by Healingstone Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10cm VAS of pain(Dysmenorrhea) (time frame: 5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2009.