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Moxibustion for Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT01972906
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Device: moxibustion Drug: Ibuprofen Sustained Release Capsules Early Phase 1

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traditional Chinese Moxibustion for Primary Dysmenorrhea
Study Start Date : February 2012
Primary Completion Date : February 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Moxibustion treatment group
Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory
Device: moxibustion
apply moxibustion according to traditional Chinese medicine
Active Comparator: Medicine control group
Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea
Drug: Ibuprofen Sustained Release Capsules
apply Ibuprofen (H20013062), 0.3g, Bid, lasting 3 days before menstrual cycle
Other Name: Fenbid

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

  4. Laboratory Index-3 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ]

  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

Eligibility Criteria

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Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972906

China, Sichuan
Affiliated hospital of Chengdu University of TCM
Chengdu, Sichuan, China, 610072
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Principal Investigator: Fanrong Liang, Professor Chengdu University of TCM
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01972906     History of Changes
Other Study ID Numbers: 2011SZ0302
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Chengdu University of Traditional Chinese Medicine:
primary dysmenorrhea

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action