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Moxibustion for Primary Dysmenorrhea

This study is currently recruiting participants.
Verified October 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01972906
First received: October 22, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Primary Dysmenorrhea
Device: moxibustion
Drug: Ibuprofen Sustained Release Capsules
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traditional Chinese Moxibustion for Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    to assess the degree of dysmenorrhea


Secondary Outcome Measures:
  • Laboratory index-1 [ Time Frame: at baseline, 4th menstrual cycle after inclusion ] [ Designated as safety issue: Yes ]
    prostaglandin (PGF2a、PGE2)

  • Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion ] [ Designated as safety issue: Yes ]
    to assess the change of symptom during menstrual cycle

  • Laboratory Index-2 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ] [ Designated as safety issue: Yes ]
    oxytocin

  • Laboratory Index-3 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ] [ Designated as safety issue: Yes ]
    β-endorphin

  • Laboratory Index-4 [ Time Frame: at baseline, 4 menstrual cycles after inclucion ] [ Designated as safety issue: Yes ]
    plasma endothelin-1

  • Laboratory Index-5 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ] [ Designated as safety issue: Yes ]
    nitric oxide

  • Laboratory Index-6 [ Time Frame: at baseline, 4 menstrual cycles after inclusion ] [ Designated as safety issue: Yes ]
    Plasma vascular pseudohemophilia factors


Estimated Enrollment: 152
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972906

Contacts
Contact: Jie Yang, PHD 13882296714 jenny_yang_jie@126.com

Locations
China, Sichuan
Affiliated hospital of Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610072
Contact: Jiao Chen, master    13518189624    cjthz@126.com   
Sub-Investigator: LinNa Bo, master         
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Principal Investigator: Fanrong Liang, Professor Chengdu University of TCM
  More Information

No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01972906     History of Changes
Other Study ID Numbers: 2011SZ0302
Study First Received: October 22, 2013
Last Updated: October 25, 2013
Health Authority: China: Science and Technology Department of Sichuan Province

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

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

ClinicalTrials.gov processed this record on April 17, 2014