Moxibustion for Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Traditional Chinese Moxibustion for Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972906
• Other study ID #: 2011SZ0302
• Status: Completed
• Phase: Phase 0
• First received: October 22, 2013
• Last updated: November 25, 2014
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Department of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• moxibustion
apply moxibustion according to traditional Chinese medicine

Drug:
• Ibuprofen Sustained Release Capsules
apply Ibuprofen (H20013062), 0.3g, Bid, lasting 3 days before menstrual cycle

Locations

Country	Name	City	State
China	Affiliated hospital of Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Laboratory index-1	prostaglandin (PGF2a?PGE2)	at baseline, 4th menstrual cycle after inclusion	Yes
Secondary	Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale	to assess the change of symptom during menstrual cycle	1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion	Yes
Secondary	Laboratory Index-2	oxytocin	at baseline, 4 menstrual cycles after inclusion	Yes
Secondary	Laboratory Index-3	ß-endorphin	at baseline, 4 menstrual cycles after inclusion	Yes
Secondary	Laboratory Index-4	plasma endothelin-1	at baseline, 4 menstrual cycles after inclucion	Yes
Secondary	Laboratory Index-5	nitric oxide	at baseline, 4 menstrual cycles after inclusion	Yes
Secondary	Laboratory Index-6	Plasma vascular pseudohemophilia factors	at baseline, 4 menstrual cycles after inclusion	Yes