Treatment of Primary Menstrual Pain With Kanion Capsule

February 2, 2010 updated by: Lianyungang Kanion Group, Ltd.

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.

Study Overview

Status

Completed

Conditions

Primary Dysmenorrhea

Intervention / Treatment

Drug: Kanion Capsule

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Georgia
  - Sandy Springs, Georgia, United States, 30328
    - Mount Vernon Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

primary dysmenorrhea

Exclusion Criteria:

secondary dysmenorrhea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain reduction Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
accompanying symptoms improvement Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lianyungang Kanion Group, Ltd.

Investigators

Study Chair: Jun Shao, Ph.D., Biokey Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria