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NCT00523146 Clinical Trial

Treatment of Primary Menstrual Pain With Kanion Capsule

Primary Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00523146
Other study ID # GF-2006-001
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2007
Last updated February 2, 2010
Start date April 2007
Est. completion date February 2009

Study information
Verified date February 2010
Source Lianyungang Kanion Group, Ltd.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- primary dysmenorrhea

Exclusion Criteria:

- secondary dysmenorrhea

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Kanion Capsule

Locations
Country Name City State
United States Mount Vernon Clinical Research, LLC Sandy Springs Georgia

Sponsors (1)
Lead Sponsor Collaborator
Lianyungang Kanion Group, Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain reduction 6 months
Secondary accompanying symptoms improvement 6 months
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