Treatment of Primary Menstrual Pain With Kanion Capsule

This study has been completed.
Information provided by:
Lianyungang Kanion Group, Ltd. Identifier:
First received: August 29, 2007
Last updated: February 2, 2010
Last verified: February 2010

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

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)

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

Inclusion Criteria:

  • primary dysmenorrhea

Exclusion Criteria:

  • secondary dysmenorrhea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00523146

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

No publications provided 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:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Signs and Symptoms processed this record on November 25, 2015