Clinical trial NCT01972906: Moxibustion for Primary Dysmenorrhea
Official title: Traditional Chinese Moxibustion for Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Primary Dysmenorrhea
Keywords: moxibustion
primary dysmenorrhea
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 152
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change from baseline in menstrual pain intensity measured by VAS at 6 months
timeFrame: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion
Secondary outcomes:
measure: Laboratory index-1
timeFrame: at baseline, 4th menstrual cycle after inclusion
measure: Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion
measure: Laboratory Index-2
timeFrame: at baseline, 4 menstrual cycles after inclusion
measure: Laboratory Index-3
timeFrame: at baseline, 4 menstrual cycles after inclusion
measure: Laboratory Index-4
timeFrame: at baseline, 4 menstrual cycles after inclucion
measure: Laboratory Index-5
timeFrame: at baseline, 4 menstrual cycles after inclusion
measure: Laboratory Index-6
timeFrame: at baseline, 4 menstrual cycles after inclusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affiliated hospital of Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fanrong Liang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.