Moxibustion for Primary Dysmenorrhea

Early Phase 1

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Drug: Ibuprofen Sustained Release Capsules; Device: moxibustion

• Registration Number: NCT01972906
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Primary Completion: 2014-02
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medicine control group	Ibuprofen Sustained Release Capsules	Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea
Moxibustion treatment group	moxibustion	Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Laboratory index-1	at baseline, 4th menstrual cycle after inclusion	prostaglandin (PGF2a、PGE2)
Laboratory Index-2	at baseline, 4 menstrual cycles after inclusion	oxytocin
Laboratory Index-5	at baseline, 4 menstrual cycles after inclusion	nitric oxide
Laboratory Index-4	at baseline, 4 menstrual cycles after inclucion	plasma endothelin-1
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-6	at baseline, 4 menstrual cycles after inclusion	Plasma vascular pseudohemophilia factors
Laboratory Index-3	at baseline, 4 menstrual cycles after inclusion	β-endorphin

Trial Locations

Locations (1)

Affiliated hospital of Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China