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Moxibustion for Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

moxibustion

Ibuprofen Sustained Release Capsules

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring moxibustion, primary dysmenorrhea

Eligibility Criteria

13 Years - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Affiliated hospital of Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxibustion treatment group

Medicine control group

Arm Description

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

Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea

Outcomes

Primary Outcome Measures

change from baseline in menstrual pain intensity measured by VAS at 6 months

to assess the degree of dysmenorrhea

Secondary Outcome Measures

Laboratory index-1

prostaglandin (PGF2a、PGE2)

Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale

to assess the change of symptom during menstrual cycle

Laboratory Index-2

oxytocin

Laboratory Index-3

β-endorphin

Laboratory Index-4

plasma endothelin-1

Laboratory Index-5

nitric oxide

Laboratory Index-6

Plasma vascular pseudohemophilia factors

Full Information

NCT ID

NCT01972906

First Posted

October 22, 2013

Last Updated

November 25, 2014

Sponsor

Chengdu University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01972906

Brief Title

Moxibustion for Primary Dysmenorrhea

Official Title

Traditional Chinese Moxibustion for Primary Dysmenorrhea

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

moxibustion, primary dysmenorrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxibustion treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Medicine control group

Arm Type

Active Comparator

Arm Description

Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea

Intervention Type

Device

Intervention Name(s)

moxibustion

Intervention Description

apply moxibustion according to traditional Chinese medicine

Intervention Type

Drug

Intervention Name(s)

Ibuprofen Sustained Release Capsules

Other Intervention Name(s)

Fenbid

Intervention Description

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

Primary Outcome Measure Information:

Title

change from baseline in menstrual pain intensity measured by VAS at 6 months

Description

to assess the degree of dysmenorrhea

Time Frame

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

Secondary Outcome Measure Information:

Title

Laboratory index-1

Description

prostaglandin (PGF2a、PGE2)

Time Frame

at baseline, 4th menstrual cycle after inclusion

Title

Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale

Description

to assess the change of symptom during menstrual cycle

Time Frame

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

Title

Laboratory Index-2

Description

oxytocin

Time Frame

at baseline, 4 menstrual cycles after inclusion

Title

Laboratory Index-3

Description

β-endorphin

Time Frame

at baseline, 4 menstrual cycles after inclusion

Title

Laboratory Index-4

Description

plasma endothelin-1

Time Frame

at baseline, 4 menstrual cycles after inclucion

Title

Laboratory Index-5

Description

nitric oxide

Time Frame

at baseline, 4 menstrual cycles after inclusion

Title

Laboratory Index-6

Description

Plasma vascular pseudohemophilia factors

Time Frame

at baseline, 4 menstrual cycles after inclusion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fanrong Liang, Professor

Organizational Affiliation

Chengdu University of TCM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Affiliated hospital of Chengdu University of TCM

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

28170396

Citation

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.

Results Reference

derived

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Moxibustion for Primary Dysmenorrhea

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