An interventional study of Hand-acupuncture and Electrico-acupuncture in Menopause and Puncture Site Reaction, sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. Completed at 1 site in China. Open to female participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · Not applicable, Interventional, and Supportive care
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
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 · Device: Electrico-acupuncture
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 · Device: Electrico-acupuncture
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.
Also known as: Use Hua Tuo brand disposable acupuncture needles
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.
Also known as: SDZ electro-acupuncture device
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.
Time frame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
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
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.
Time frame: into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.
safety evaluation of acupuncture
Content including broken needle, and left needle, and during, and acupuncture pain and the VAS scoring, and difficult endured of acupuncture pain (VAS ≥ 8 points, 10 points system), and needle Hou pain and the scoring, and continued time over 2 hours of more dramatic of needle Hou pain (VAS ≥ 4 points, 10 points system), and local hematoma, and infection or abscess; acupuncture Hou other does not apply sense (refers to acupuncture Hou appeared of fatigue, and palpitations, and dizzy, and headache, and insomnia, symptoms of VAS scoring of average degree and the average continued time; other is not foreseen of bad event. Form sheet for specific, when the diagnosis and treatment of patients at a time, asks if there are adverse events and reactions, if any, immediate records.
Time frame: immediate records
evaluation of discomfort when acupuncturing
evaluation of VAS maximum discomfort occurs during treatment.
Time frame: 1TH and 12th within 5 minutes after the end of acupuncture treatment, take these two averages. Where a VAS value is missing, a VAS for the result.
subjects acceptance evaluation
an evaluation using the 0-4 system, that is divided into unacceptable (0 points), is more difficult to accept (1), moderate access (2 points), the more acceptable (3 points), very easy to take (4 points), causes unacceptable to write out.
Time frame: 1TH and 12th at the end of treatment with acupuncture and moxibustion, and taking the average.
health economics indexes
Includes direct medical costs (check fees, fees and other costs of acupuncture and moxibustion) and hidden costs (such as round trip transportation, lost)
Time frame: into the group after 8th during recording.
research evaluation
Compliance, rejection and expulsion rates
Time frame: to 32nd after into the Group during recording
The record gives a start of Apr 2014, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine