Moxibustion for Primary Dysmenorrhea

Early Phase 1CompletedNCT01972906

Chengdu University of Traditional Chinese Medicine152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Primary Dysmenorrhea

Interventions

moxibustionDEVICE

apply moxibustion according to traditional Chinese medicine

Ibuprofen Sustained Release CapsulesDRUG

apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

change from baseline in menstrual pain intensity measured by VAS at 6 months

to assess the degree of dysmenorrhea

Time frame: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion

Secondary Outcomes

Laboratory index-1

prostaglandin (PGF2a、PGE2)

Time frame: at baseline, 4th menstrual cycle after inclusion

Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale

to assess the change of symptom during menstrual cycle

Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion

Laboratory Index-2

oxytocin

Time frame: at baseline, 4 menstrual cycles after inclusion

Laboratory Index-3

β-endorphin

Time frame: at baseline, 4 menstrual cycles after inclusion

Laboratory Index-4

plasma endothelin-1

Time frame: at baseline, 4 menstrual cycles after inclucion

Laboratory Index-5

nitric oxide

Time frame: at baseline, 4 menstrual cycles after inclusion

Laboratory Index-6

Plasma vascular pseudohemophilia factors

Time frame: at baseline, 4 menstrual cycles after inclusion

Data from ClinicalTrials.gov

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