Moxibustion for Primary Dysmenorrhea

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Traditional Chinese Moxibustion for Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Device: moxibustion
* Drug: Ibuprofen Sustained Release Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in menstrual pain intensity measured by VAS at 6 months | to assess the degree of dysmenorrhea | at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxibustion, primary dysmenorrhea