Vitamin K Injections for the Treatment of Painful Menstruation
Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2004
1 active site
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 1, 2005
CompletedFirst Posted
Study publicly available on registry
March 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJanuary 25, 2008
January 1, 2008
1.5 years
March 1, 2005
January 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS)
presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy
Cox retrospective symptom scale
Moos score
Interventions
Eligibility Criteria
You may qualify if:
- Dysmenorrhea for at least 6 months prior to study entry
- Have never been pregnant or have given birth
- Mandarin Chinese or Shanghainese speaking
- Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
- Has a working home phone or cellular phone
- Willing to disclose address
- Intends to stay in the area during the study
- Parent or guardian willing to provide informed consent, if applicable
You may not qualify if:
- Dysmenorrhea due to any suspected or recognized causes
- Current use of hormonal contraceptives or an intrauterine device
- History of abdominal surgery
- Other concomitant therapy for acute or chronic pain
- Anticoagulant drugs
- Vitamin K acu-injections at leg acupuncture points prior to study entry
- Intolerance to NSAIDs
- Known allergy to vitamin K
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University
Shanghai, China
Related Publications (1)
Wade C, Wang L, Zhao WJ, Cardini F, Kronenberg F, Gui SQ, Ying Z, Zhao NQ, Chao MT, Yu J. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study. BMJ Open. 2016 Jan 5;6(1):e008166. doi: 10.1136/bmjopen-2015-008166.
PMID: 26733563DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredi Kronenberg, PhD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 1, 2005
First Posted
March 2, 2005
Study Start
September 1, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
January 25, 2008
Record last verified: 2008-01