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NCT Number: NCT01972906

Moxibustion for Primary Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea

Age range

13 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, 610072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Guidelines of Primary dysmenorrhea clinical by the Society of Obstetricians and Gynaecologists of Canada
  • Menstrual cycle is regular (28±7) days
  • Syndrome differentiation of Traditional Chinese Medicine: Congealing cold-damp and Qi-stagnation and blood stasis
  • Mean value of ≥40mm during last 3 months
  • Informed consent form must be signed by patient or lineal relative

Exclusion criteria

  • Patients with secondary dysmenorrhea, which is caused by endometriosis, pelvic inflammation, myoma of uterus and so on
  • Patients who are unconscious and psychotic
  • Patients with serious primary illness or diseases of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on
  • Patients take prostaglandin synthetase inhibitors (PGSI) 2 weeks before inclusion
  • Pregnant women or women in lactation

Treatment and study plan

moxibustion

Device

apply moxibustion according to traditional Chinese medicine

Ibuprofen Sustained Release Capsules

Drug

apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle

Other names: Fenbid

Primary outcomes

  1. 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

Secondary outcomes

  1. Laboratory index-1

    Time frame: at baseline, 4th menstrual cycle after inclusion

    prostaglandin (PGF2a、PGE2)

  2. 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

  3. Laboratory Index-2

    Time frame: at baseline, 4 menstrual cycles after inclusion

    oxytocin

  4. Laboratory Index-3

    Time frame: at baseline, 4 menstrual cycles after inclusion

    β-endorphin

  5. Laboratory Index-4

    Time frame: at baseline, 4 menstrual cycles after inclucion

    plasma endothelin-1

  6. Laboratory Index-5

    Time frame: at baseline, 4 menstrual cycles after inclusion

    nitric oxide

  7. Laboratory Index-6

    Time frame: at baseline, 4 menstrual cycles after inclusion

    Plasma vascular pseudohemophilia factors

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

Traditional Chinese Moxibustion for Primary Dysmenorrhea

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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