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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxibustion treatment group | Experimental | Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory |
|
| Medicine control group | Active Comparator | Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxibustion | Device | apply moxibustion according to traditional Chinese medicine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanrong Liang, Professor | Chengdu University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Chengdu University of TCM | Chengdu | Sichuan | 610072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28170396 | Derived | Yang M, Chen X, Bo L, Lao L, Chen J, Yu S, Yu Z, Tang H, Yi L, Wu X, Yang J, Liang F. Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial. PLoS One. 2017 Feb 7;12(2):e0170952. doi: 10.1371/journal.pone.0170952. eCollection 2017. |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| C510019 | fenbid |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Ibuprofen Sustained Release Capsules | Drug | apply Ibuprofen (H20013062), 0.3g, Bid, lasting 3 days before 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 |