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Treatment of Primary Menstrual Pain With Kanion Capsule

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ClinicalTrials.gov Identifier: NCT00523146
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Lianyungang Kanion Group, Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Drug: Kanion Capsule Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. pain reduction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. accompanying symptoms improvement [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary dysmenorrhea

Exclusion Criteria:

  • secondary dysmenorrhea

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): NCT00523146


Locations
United States, Georgia
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
Sponsors and Collaborators
Lianyungang Kanion Group, Ltd.
Investigators
Study Chair: Jun Shao, Ph.D. Biokey Inc.

ClinicalTrials.gov Identifier: NCT00523146     History of Changes
Other Study ID Numbers: GF-2006-001
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by Lianyungang Kanion Group, Ltd.:
primary dysmenorrhea
Herbal remedy

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