Primary DysmenorrheaEarly Phase 1NCT01972906
Moxibustion for Primary Dysmenorrhea
A Early Phase 1 study testing moxibustion and Ibuprofen Sustained Release Capsules in people with Primary Dysmenorrhea, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 13 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- moxibustion and Ibuprofen Sustained Release Capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Jun 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated hospital of Chengdu University of TCM
Chengdu, Sichuan, 610072
About this study
Official title: Traditional Chinese Moxibustion for Primary Dysmenorrhea
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- moxibustion, Ibuprofen Sustained Release Capsules
- Keywords
- moxibustion, primary dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxibustionDevice
apply moxibustion according to traditional Chinese medicine
Ibuprofen Sustained Release CapsulesDrug
Also called Fenbid
apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion treatment group | Experimental | Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory Receives: Device: moxibustion |
| Medicine control group | Active comparator | Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea Receives: Drug: Ibuprofen Sustained Release Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in menstrual pain intensity measured by VAS at 6 months
to assess the degree of dysmenorrhea
Measured: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion
Secondary outcomes (7)
Laboratory index-1
prostaglandin (PGF2a、PGE2)
Measured: at baseline, 4th menstrual cycle after inclusion
Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale
to assess the change of symptom during menstrual cycle
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion
Laboratory Index-2
oxytocin
Measured: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-3
β-endorphin
Measured: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-4
plasma endothelin-1
Measured: at baseline, 4 menstrual cycles after inclucion
Laboratory Index-5
nitric oxide
Measured: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-6
Plasma vascular pseudohemophilia factors
Measured: at baseline, 4 menstrual cycles after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanrong Liang, Professor, Principal investigator, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972906
- Sponsor's protocol ID
- 2011SZ0302
- Status last verified
- Nov 2014
- First submitted
- 22 Oct 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28170396
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Moxibustion for Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT01972906
- Acronym / sponsor ID
- 2011SZ0302
- Conditions
- Primary Dysmenorrhea
- Keywords
- moxibustion, primary dysmenorrhea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion treatment group | Experimental | Device: moxibustionApply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory |
| Medicine control group | Active comparator | Drug: Ibuprofen Sustained Release CapsulesIbuprofen Sustained Release Capsules will be penetrated for dysmenorrhea |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moxibustionapply moxibustion according to traditional Chinese medicine | Device | Moxibustion treatment group |
| Ibuprofen Sustained Release CapsulesAlso: Fenbidapply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle | Drug | Medicine control group |
Primary outcome
change from baseline in menstrual pain intensity measured by VAS at 6 months
Time frame: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion
to assess the degree of dysmenorrhea
7 secondary outcomes
Laboratory index-1
Time frame: at baseline, 4th menstrual cycle after inclusion
Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion
Laboratory Index-2
Time frame: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-3
Time frame: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-4
Time frame: at baseline, 4 menstrual cycles after inclucion
Laboratory Index-5
Time frame: at baseline, 4 menstrual cycles after inclusion
Laboratory Index-6
Time frame: at baseline, 4 menstrual cycles after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 28170396Yang 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.
Related trials for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanrong Liang, Professor principal investigator
Chengdu University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing moxibustion and Ibuprofen Sustained Release Capsules in people with Primary Dysmenorrhea, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in menstrual pain intensity measured by VAS at 6 months (time frame: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01972906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.