NCT01972906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

October 22, 2013

Last Update Submit

November 25, 2014

Conditions

Primary Dysmenorrhea

Keywords

moxibustionprimary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Laboratory index-1

    at baseline, 4th menstrual cycle after inclusion

  • Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale

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

  • Laboratory Index-2

    at baseline, 4 menstrual cycles after inclusion

  • Laboratory Index-3

    at baseline, 4 menstrual cycles after inclusion

  • Laboratory Index-4

    at baseline, 4 menstrual cycles after inclucion

  • +2 more secondary outcomes

Study Arms (2)

Moxibustion treatment group

EXPERIMENTAL

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

Device: moxibustion

Medicine control group

ACTIVE COMPARATOR

Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea

Drug: Ibuprofen Sustained Release Capsules

Interventions

moxibustionDEVICE

apply moxibustion according to traditional Chinese medicine

Moxibustion treatment group
Ibuprofen Sustained Release CapsulesDRUG

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

Also known as: Fenbid
Medicine control group

Eligibility Criteria

Age13 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnant women or women in lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, 610072, China

Location

Related Publications (1)

  • 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.

    PMID: 28170396DERIVED

MeSH Terms

Interventions

Moxibustionfenbid

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Fanrong Liang, Professor

    Chengdu University of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 31, 2013

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

CN(1)