Back to resultsTreatment of Primary Menstrual Pain With Kanion Capsule
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Kanion Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, Herbal remedy
Eligibility Criteria
Inclusion Criteria:
- primary dysmenorrhea
Exclusion Criteria:
- secondary dysmenorrhea
Sites / Locations
- Mount Vernon Clinical Research, LLC
Outcomes
Primary Outcome Measures
pain reduction
Secondary Outcome Measures
accompanying symptoms improvement
Full Information
NCT ID
NCT00523146
First Posted
August 29, 2007
Last Updated
February 2, 2010
Sponsor
Lianyungang Kanion Group, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00523146
Brief Title
Treatment of Primary Menstrual Pain With Kanion Capsule
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lianyungang Kanion Group, Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
primary dysmenorrhea, Herbal remedy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Kanion Capsule
Primary Outcome Measure Information:
Title
pain reduction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
accompanying symptoms improvement
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary dysmenorrhea
Exclusion Criteria:
secondary dysmenorrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Shao, Ph.D.
Organizational Affiliation
Biokey Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Primary Menstrual Pain With Kanion Capsule
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