Moxibustion for Primary Dysmenorrhea

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Early Phase 1

Conditions: Primary Dysmenorrhea

Treatments: Device: moxibustion; Drug: Ibuprofen Sustained Release Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT01972906

2011SZ0302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: Female

Ages: 13 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Moxibustion treatment group

Experimental group

Description:

Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory

Treatment:

Device: moxibustion

Medicine control group

Active Comparator group

Description:

Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea

Treatment:

Drug: Ibuprofen Sustained Release Capsules