MenopauseNCT02098928
Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause
A study testing Hand-acupuncture and Electrico-acupuncture in people with Menopause and Puncture Site Reaction, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Menopause, Puncture Site Reaction
- What is being tested?
- Hand-acupuncture and Electrico-acupuncture
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Sep 2015
- Phase
- Interventional
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- in past of 12 months in, menstrual cycle not rules, menstrual ahead of or wrong Hou ≥ 7 days (menopause transition period early); in past of 12 months in, at least shedding had 2 a menstrual cycle, or amenorrhea over 60 days, but ≤ November (menopause transition period late); last once menstrual to stopped by Hou 3 years within (menopause 3 years within patients)
- Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
- 40-55 years
- Baseline scorch score ≥ 6 points
- without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
- volunteered for this study, and sign the consent form
Who cannot join
- test within 3 months before the menstrual cycle rules
- nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
- diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
- disease history of chemotherapy or who are undergoing chemotherapy
- unexplained vaginal bleeding
- coagulation disorders or taking anticoagulant drugs such as warfarin, heparin
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- suffered from skin diseases like eczema, psoriasis, etc
- severe hepatic and renal insufficiency
- yet controlled high blood pressure, diabetes, or thyroid disease
- diabetic nerve damage, cancer and mental illnesses (including depression)
- wishes are in pregnancy or pregnancy or breastfeeding
- long-term use of sedatives or antidepressants
- long-term smoking and alcoholism
- installed pacemaker or artificial joints
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliate hospital of Hunan university of chinese traditional medicine
Changsha, Hunan, 410007
About this study
Official title: Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms
Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation
- Conditions
- Menopause, Puncture Site Reaction
- Being tested
- Hand-acupuncture, Electrico-acupuncture
- Keywords
- Acupuncture, Electro acupuncture, Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-acupunctureBehavioural
Also called Use Hua Tuo brand disposable acupuncture needles
Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
Electrico-acupunctureDevice
Also called SDZ electro-acupuncture device
Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
| Study group | Role | What they receive |
|---|---|---|
| Hand-acupuncture group | Active comparator | Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. Receives: Behavioral: Hand-acupuncture; Device: Electrico-acupuncture |
| Electric-acupuncture group | Placebo comparator | Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. Receives: Behavioral: Hand-acupuncture; Device: Electrico-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
The average scores of 24 hours hot flashes integration consists of integrating the hot flashes times and hot flashes extent, hot flashes degree of mild, moderate and severe hot flashes three categories. Recorded by diary cards of hot flashes symptoms diary cards.
Measured: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Secondary outcomes (5)
Scores of menopause rating scale（MRS）
Measured: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL）
Measured: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of the Self-Rating Anxiety Scale（SAS）
Measured: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of the Self-rating depression scale（SDS）
Measured: into the group, into the group after the 4th, 8, 20 and 32 weeks.
the serum levels of sex hormones
Menstruation are required in the first 2-4 days of the menstrual blood test, then if no menstruation, menstrual cycles can wait until next month before testing; menopause, while those in the first eight weeks and 20 weekend testing.
Measured: into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Responsible party
- Sponsor
- Investigators
- zhang wei, Professor, Study chair, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098928
- Sponsor's protocol ID
- 2012BAI24B01
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms
- ClinicalTrials.gov ID
- NCT02098928
- Acronym / sponsor ID
- 2012BAI24B01
- Conditions
- Menopause, Puncture Site Reaction
- Keywords
- Acupuncture, Electro acupuncture, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Mar 2014 (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.
Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-acupuncture group | Active comparator | Behavioral: Hand-acupuncture, Device: Electrico-acupunctureUse Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
| Electric-acupuncture group | Placebo comparator | Behavioral: Hand-acupuncture, Device: Electrico-acupunctureUse Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- in past of 12 months in, menstrual cycle not rules, menstrual ahead of or wrong Hou ≥ 7 days (menopause transition period early); in past of 12 months in, at least shedding had 2 a menstrual cycle, or amenorrhea over 60 days, but ≤ November (menopause transition period late); last once menstrual to stopped by Hou 3 years within (menopause 3 years within patients)
- Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
- 40-55 years
- Baseline scorch score ≥ 6 points
- without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
Key exclusion criteria (14 listed)
- test within 3 months before the menstrual cycle rules
- nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
- diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
- disease history of chemotherapy or who are undergoing chemotherapy
- unexplained 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 |
|---|---|---|
| Hand-acupunctureAlso: Use Hua Tuo brand disposable acupuncture needlesUse Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. | Behavioural | Electric-acupuncture group, Hand-acupuncture group |
| Electrico-acupunctureAlso: SDZ electro-acupuncture deviceUse Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. | Device | Electric-acupuncture group, Hand-acupuncture group |
Primary outcome
Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
The average scores of 24 hours hot flashes integration consists of integrating the hot flashes times and hot flashes extent, hot flashes degree of mild, moderate and severe hot flashes three categories. Recorded by diary cards of hot flashes symptoms diary cards.
5 secondary outcomes
Scores of menopause rating scale（MRS）
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL）
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of the Self-Rating Anxiety Scale（SAS）
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of the Self-rating depression scale（SDS）
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
the serum levels of sex hormones
Time frame: into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.
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 3 Nov 2015.
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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.
zhang wei, Professor study chair
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-acupuncture and Electrico-acupuncture in people with Menopause and Puncture Site Reaction, run by The First Affiliated Hospital of Hunan 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 6 inclusion and 14 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 3 Nov 2015. 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?
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 average scores of 24-hour hot flashes symptoms at 32 weeks (time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015; AzTrials last refreshed its copy on 3 Nov 2026.