Primary Dysmenorrhea
Conditions
Keywords
moxibustion, 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 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.
Interventions
DEVICEmoxibustion
apply moxibustion according to traditional Chinese medicine
DRUGIbuprofen Sustained Release Capsules
apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in menstrual pain intensity measured by VAS at 6 months | at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion | to assess the degree of dysmenorrhea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale | 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion | to assess the change of symptom during menstrual cycle |
| Laboratory Index-2 | at baseline, 4 menstrual cycles after inclusion | oxytocin |
| Laboratory Index-3 | at baseline, 4 menstrual cycles after inclusion | β-endorphin |
| Laboratory index-1 | at baseline, 4th menstrual cycle after inclusion | prostaglandin (PGF2a、PGE2) |
| Laboratory Index-5 | at baseline, 4 menstrual cycles after inclusion | nitric oxide |
| Laboratory Index-6 | at baseline, 4 menstrual cycles after inclusion | Plasma vascular pseudohemophilia factors |
| Laboratory Index-4 | at baseline, 4 menstrual cycles after inclucion | plasma endothelin-1 |
Countries
China
Outcome results
None listed