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Treatment of Primary Menstrual Pain With Kanion Capsule

This study has been completed.
Sponsor:
Information provided by:
Lianyungang Kanion Group, Ltd.
ClinicalTrials.gov Identifier:
NCT00523146
First received: August 29, 2007
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Primary Dysmenorrhea
 Drug: Kanion Capsule
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Lianyungang Kanion Group, Ltd.:

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

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

Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary dysmenorrhea

Exclusion Criteria:

  • secondary dysmenorrhea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523146     History of Changes
Other Study ID Numbers: GF-2006-001
Study First Received: August 29, 2007
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013