Menopausal SyndromeNCT01849172
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
A study testing electroacupuncture in people with Menopausal Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition . Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
- Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
- 40 to 55 years old.
- Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -
Who cannot join
- Regular cycles during the past 3 months before enrollment.
- use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
- Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
- Patients with radiochemotherapy history or undergoing radiochemotherapy.
- Cryptogenic vaginal bleeding
- Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
Show all 15Show fewer
- Existing skin diseases like eczema or psoriasis.
- Severe hepatic/renal insufficiency.
- Insufficiently controlled hypertension, diabetes or thyroid diseases.
- Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
- Wish to become pregnant or is pregnant or breast-feeding.
- Regular use of sedative or anxiolytic.
- Smoking or alcohol intake.
- Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
- With cardiac pacemaker or artificial joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition -a Multicenter Randomized Controlled Trial
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
Read the detailed description
Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.
Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.
- Conditions
- Menopausal Syndrome
- Being tested
- electroacupuncture, sham electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).
sham electroacupunctureOther
Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).
Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. Receives: Other: electroacupuncture |
| sham electroacupuncture | Sham comparator | Sham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. Receives: Other: sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Menopause Rating Scale Total Score
The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline.
MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
Measured: at baseline and week 8
Secondary outcomes (15)
Change From Baseline in Menopause Rating Scale Total Score
The change in Menopause Rating Scale (MRS）total score compared with baseline at weeks 4, 20 and 32 equals MRS total score at weeks 4, 20 and 32 minus MRS total score at baseline,respectively.
MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
Measured: at baseline，and weeks 4, 20 and 32
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
The change from baseline in somatic-vegetative domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the somatic-vegetative domain of MRS at weeks 4, 8, 20 and 32 minus the somatic-vegetative domain of MRS at baseline, respectively.
The somatic-vegetative domain contains 4 items (items 1-3 and 11). Each of the item scores ranges from 0 to 4. The somatic-vegetative domain score will be calculated as the all somatic-vegetative items ranging from 0 to 16, with higher scores indicating worse symptoms.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Psychological Domain of Menopause Rating Scale
The change from baseline in psychological domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the psychological domain of MRS at weeks 4, 8, 20 and 32 minus the psychological domain of MRS at baseline, respectively.
The psychological domain contains 4 items (items 4-7). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all psychological items ranging from 0 to 16, with higher scores indicating worse symptoms.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Urogenital Domain of Menopause Rating Scale
The change from baseline in urogenital domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the urogenital domain of MRS at weeks 4, 8, 20 and 32 minus the urogenital domain of MRS at baseline, respectively.
The urogenital domain contains 3 items (items 8-10). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all urogenital items ranging from 0 to 12, with higher scores indicating worse symptoms.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Mean 24-h Hot Flash Score
The 24-h hot flash score was daily hot flash episodes multiplied by the corresponding severities. The change from baseline in mean 24-h HF score at weeks 4, 8, 20 and 32 equals the mean 24-h HF score at weeks 4 , 8, 20 and 32 minus the mean 24-h HF score at baseline, respectively.
Hot flashes score consisted the number and the degree of hot flashes. The hot flashes score is the sum of the scores of all the hot flashes occurring in a whole day, with a higher score indicating worse symptoms. A 3-point rating scale allows the women to describe the perceived severity of hot flash. 1 point = mild hot flash, 2 point = moderate hot flash, 3 point = severe hot flash.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
The change from baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) total score at weeks 4, 8, 20 and 32 equals the MENQOL total score at weeks 4, 8, 20 and 32 minus the MENQOL score at baseline, respectively.
It composed of 29 items and was divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Each of the item scores ranges from 0 to 6. The total score will be calculated as the all items ranging from 0 to 174, with lower scores indicating a better quality of life.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
The change from baseline in the vasomotor domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the vasomotor domain of MENQOL at weeks 4, 8, 20 and 32 minus the vasomotor domain of MENQOL at baseline, respectively.
The vasomotor domain contains 3 items (items 1-3). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all vasomotor items ranging from 0 to 18, with lower scores indicating a better quality of life.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
The change from baseline in the psychosocial domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the psychosocial domain of MENQOL at weeks 4, 8, 20 and 32 minus the psychosocial domain of MENQOL at baseline, respectively.
The psychosocial domain contains 7 items (items 4-10). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all psychosocial items ranging from 0 to 42, with lower scores indicating a better quality of life.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
The change from baseline in the physical domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the physical domain of MENQOL at weeks 4, 8, 20 and 32 minus the physical domain of MENQOL at baseline, respectively.
The physical domain contains 16 items (items 11-26). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all physical items ranging from 0 to 96, with lower scores indicating a better quality of life.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
The change from baseline in the sexual functioning domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the sexual functioning domain of MENQOL at weeks 4, 8, 20 and 32 minus the sexual functioning domain of MENQOL at baseline, respectively.
The sexual functioning domain contains 3 items (items 27-29). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all sexual functioning items ranging from 0 to 18, with lower scores indicating a better quality of life.
Measured: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Serum FSH Level
The change from baseline in serum FSH level at weeks 8 and 20 equals FSH at weeks 8 and 20 minus FSH at baseline, respectively.
Measured: at baseline, and weeks 8 and 20
Change From Baseline in Serum E2 Level
The change from baseline in serum E2 level at weeks 8 and 20 equals E2 at weeks 8 and 20 minus E2 at baseline, respectively.
Measured: at baseline, and weeks 8 and 20
Change From Baseline in Serum LH Level
The change from baseline in serum LH level at weeks 8 and 20 equals LH at weeks 8 and 20 minus LH at baseline, respectively.
Measured: at baseline, and weeks 8 and 20
Change From Baseline in Serum FSH/LH Level
The change from baseline in serum FSH/LH at weeks 8 and 20 equals FSH/LH at weeks 8 and 20 minus FSH/LH at baseline, respectively.
Measured: at baseline, weeks 8 and 20
Number of Participants Who Used Other Treatment During Study
The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.
Measured: weeks 1-8; weeks 9-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromeStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Ph.D, Study chair, Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849172
- Sponsor's protocol ID
- BAI24B01
- Status last verified
- Mar 2019
- First submitted
- 5 May 2013
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liu Z, Wang Y, Xu H, Wu J, He L, Jiang JY, Yan S, Du R, Liu B. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242.
PubMed 24950841
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition -a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01849172
- Acronym / sponsor ID
- BAI24B01
- Conditions
- Menopausal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Posted 25 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
Detailed description
Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.
Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Other: electroacupunctureElectroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. |
| sham electroacupuncture | Sham comparator | Other: sham electroacupunctureSham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
- Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
- 40 to 55 years old.
- Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -
Key exclusion criteria (15 listed)
- Regular cycles during the past 3 months before enrollment.
- use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
- Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
- Patients with radiochemotherapy history or undergoing radiochemotherapy.
- Cryptogenic vaginal bleeding
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 |
|---|---|---|
| electroacupunctureStick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all). | Other | electroacupuncture |
| sham electroacupunctureNon-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6). Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually. | Other | sham electroacupuncture |
Primary outcome
Change From Baseline in Menopause Rating Scale Total Score
Time frame: at baseline and week 8
The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
15 secondary outcomes
Change From Baseline in Menopause Rating Scale Total Score
Time frame: at baseline，and weeks 4, 20 and 32
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Psychological Domain of Menopause Rating Scale
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Urogenital Domain of Menopause Rating Scale
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Mean 24-h Hot Flash Score
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Time frame: at baseline, and weeks 4, 8, 20 and 32
Change From Baseline in Serum FSH Level
Time frame: at baseline, and weeks 8 and 20
Change From Baseline in Serum E2 Level
Time frame: at baseline, and weeks 8 and 20
Change From Baseline in Serum LH Level
Time frame: at baseline, and weeks 8 and 20
Change From Baseline in Serum FSH/LH Level
Time frame: at baseline, weeks 8 and 20
Number of Participants Who Used Other Treatment During Study
Time frame: weeks 1-8; weeks 9-32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24950841Liu Z, Wang Y, Xu H, Wu J, He L, Jiang JY, Yan S, Du R, Liu B. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242.
- Individual participant dataSharing planned: No
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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.
Zhishun Liu, Ph.D study chair
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Menopausal Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 4 inclusion and 15 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 Apr 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Menopause Rating Scale Total Score (time frame: at baseline and week 8). 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 NCT01849172, 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 Apr 2019.