MedDataX Logo

Moxibustion for Primary Dysmenorrhea

NCT ID: NCT01972906

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moxibustion treatment group

Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory

Group Type EXPERIMENTAL

moxibustion

Intervention Type DEVICE

apply moxibustion according to traditional Chinese medicine

Medicine control group

Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea

Group Type ACTIVE_COMPARATOR

Ibuprofen Sustained Release Capsules

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

moxibustion

apply moxibustion according to traditional Chinese medicine

Intervention Type DEVICE

Ibuprofen Sustained Release Capsules

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fenbid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fanrong Liang, Professor

Role: PRINCIPAL_INVESTIGATOR

Chengdu University of TCM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28170396 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011SZ0302

Identifier Type: -

Identifier Source: org_study_id