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

NCT02098928 | Completed DMC

• 1 other identifier: 2012BAI24B01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Menopause; Puncture Site Reaction

Keywords

Acupuncture; Electro acupuncture; Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.

Other Outcomes (5)

• safety evaluation of acupuncture

  immediate records

• evaluation of discomfort when acupuncturing

  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

  1TH and 12th at the end of treatment with acupuncture and moxibustion, and taking the average.

Study Arms (2)

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.

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.

Behavioral: Hand-acupuncture; Device: Electrico-acupuncture

Interventions

Hand-acupuncture BEHAVIORAL

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

Electric-acupuncture group; Hand-acupuncture group

Electrico-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.

Also known as: SDZ electro-acupuncture device

Electric-acupuncture group; Hand-acupuncture group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead
• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: collaborator

Study Sites (1)

The first affiliate hospital of Hunan university of chinese traditional medicine

Changsha, Hunan, 410007, China

Location

Study Officials

• zhang wei, Professor

  The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 28, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2014-03

Locations

CN (1)