Primary DysmenorrheaPhase 2NCT00523146
Treatment of Primary Menstrual Pain With Kanion Capsule
A Phase 2 study testing Kanion Capsule in people with Primary Dysmenorrhea, run by Lianyungang Kanion Group, Ltd. at 1 site in United States.
Trial summary
The objectives of this clinical trial are: To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects; To further evaluate the efficacy of GF in treatment of primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Kanion Capsule
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2009
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primary dysmenorrhea
Who cannot join
- secondary dysmenorrhea
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
About this study
Official title: Treatment of Primary Dysmenorrhea With Kanion Capsule (GF) A Randomized, Double-blind, Placebo-controlled, Repeated-Dose and Multi-Center Clinical Phase II Trial
The objectives of this clinical trial are:
- To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;
- To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Kanion Capsule
- Keywords
- primary dysmenorrhea, Herbal remedy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanion CapsuleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
Measured: 6 months
Secondary outcomes (1)
accompanying symptoms improvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionFeb 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Lianyungang Kanion Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jun Shao, Ph.D., Study chair, Biokey Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523146
- Sponsor's protocol ID
- GF-2006-001
- Status last verified
- Feb 2010
- First submitted
- 29 Aug 2007
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Primary Dysmenorrhea With Kanion Capsule (GF) A Randomized, Double-blind, Placebo-controlled, Repeated-Dose and Multi-Center Clinical Phase II Trial
- ClinicalTrials.gov ID
- NCT00523146
- Acronym / sponsor ID
- GF-2006-001
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, Herbal remedy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Lianyungang Kanion Group, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 31 Aug 2007 (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 objectives of this clinical trial are:
- To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;
- To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- primary dysmenorrhea
Key exclusion criteria (1 listed)
- secondary dysmenorrhea
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 |
|---|---|---|
| Kanion Capsule | Drug | – |
Primary outcome
pain reduction
Time frame: 6 months
1 secondary outcome
accompanying symptoms improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
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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.
Jun Shao, Ph.D. study chair
Biokey Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kanion Capsule in people with Primary Dysmenorrhea, run by Lianyungang Kanion Group, Ltd. at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain reduction (time frame: 6 months). 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 3 Feb 2010.