Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause

Study Overview
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Brief Summary
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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

Official Title
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Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms

Conditions
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Menopause, Puncture Site Reaction

Intervention / Treatment
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* Behavioral: Hand-acupuncture
* Device: Electrico-acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand-acupuncture group<br>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. | Behavioral: Hand-acupuncture<br>* 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.<br>* Other names: Use Hua Tuo brand disposable acupuncture needles;Device: Electrico-acupuncture<br>* 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.<br>* Other names: SDZ electro-acupuncture device;|
| Placebo Comparator: Electric-acupuncture group<br>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. | Behavioral: Hand-acupuncture<br>* 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.<br>* Other names: Use Hua Tuo brand disposable acupuncture needles;Device: Electrico-acupuncture<br>* 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.<br>* Other names: SDZ electro-acupuncture device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | into the group, into the group after the 4th, 8, 20 and 32 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of menopause rating scale（MRS） |  | into the group, into the group after the 4th, 8, 20 and 32 weeks. | 
| Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL） |  | into the group, into the group after the 4th, 8, 20 and 32 weeks. | 
| Scores of the Self-Rating Anxiety Scale（SAS） |  | into the group, into the group after the 4th, 8, 20 and 32 weeks. | 
| Scores of the Self-rating depression scale（SDS） |  | 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. | into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Electro acupuncture, Menopause