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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01972906
Other study ID # 2011SZ0302
Secondary ID
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


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
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