Vitamin K Injections for the Treatment of Painful Menstruation

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00104546
First received: March 1, 2005
Last updated: January 23, 2008
Last verified: January 2008

March 1, 2005
January 23, 2008
September 2004
March 2006   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00104546 on ClinicalTrials.gov Archive Site
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Vitamin K Injections for the Treatment of Painful Menstruation
Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study

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.

Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.

This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Dysmenorrhea
Procedure: Acupuncture point injection of vitamin K
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
14 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00104546
R21 AT001957
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Fredi Kronenberg, PhD Columbia University College of Physicians and Surgeons
National Center for Complementary and Alternative Medicine (NCCAM)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP