NCT00523146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

August 29, 2007

Last Update Submit

February 2, 2010

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrheaHerbal remedy

Outcome Measures

Primary Outcomes (1)

  • pain reduction

    6 months

Secondary Outcomes (1)

  • accompanying symptoms improvement

    6 months

Interventions

Kanion CapsuleDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary dysmenorrhea

You may not qualify if:

  • secondary dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Study Officials

  • Jun Shao, Ph.D.

    Biokey Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 31, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(1)