Clinical Trial: Moxibustion for Primary Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Traditional Chinese Moxibustion for Primary Dysmenorrhea

Brief Summary: Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized controlled trial. 152 participants will be included. Two arms: moxibustion treatment group and ibuprofen control group.

Detailed Summary: There is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due to low methodologic quality and small sample size. The investigators designed the random clinical trial to investigates the effectiveness of moxibustion in treating primary dysmenorrhea, the purpose of this study is to provide the research base of moxibustion efficacy. The investigators also examined the acceptability and any adverse effects associated with the use of moxibustion.
Sponsor: Chengdu University of Traditional Chinese Medicine

Current Primary Outcome: change from baseline in menstrual pain intensity measured by VAS at 6 months [ Time Frame: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion ]

to assess the degree of dysmenorrhea


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Laboratory index-1 [ Time Frame: at baseline, 4th menstrual cycle after inclusion ]
    prostaglandin (PGF2a、PGE2)
  • Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion ]
    to assess the change of symptom during menstrual cycle
  • Laboratory Index-2 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ]
    oxytocin
  • Laboratory Index-3 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ]
    β-endorphin
  • Laboratory Index-4 [ Time Frame: at baseline, 4 menstrual cycles after inclucion ]
    plasma endothelin-1
  • Laboratory Index-5 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ]
    nitric oxide
  • Laboratory Index-6 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ]
    Plasma vascular pseudohemophilia factors


Original Secondary Outcome: Same as current

Information By: Chengdu University of Traditional Chinese Medicine

Dates:
Date Received: October 22, 2013
Date Started: February 2012
Date Completion:
Last Updated: November 25, 2014
Last Verified: November 2014