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Not yet recruiting NCT07437001

Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women

No phase Interventional Postmenopausal Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medical treatment, Hypocaloric diet, Electroacupuncture.
Who it may be relevant to
Registry conditions: Postmenopausal Women. Basic parameters: 50 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women: A Randomized Controlled Trial

Overview

The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.

Detailed description

Post menopause is the time after you've been without a menstrual period for 12 months. It lasts for the rest of your life. During this stage, menopausal symptoms, such as hot flashes, get milder or go away.

Electro-acupuncture has a major advantage that it's the margin of error in needle placement for electro-acupuncture is greater than for manual therapy and therefore a less accurate placement is required, as the current spreads and may reach a nerve several millimeters away.

In electro-acupuncture, the therapist inserts the acupuncture needles in acupuncture points and electric current is connected to the body through the acupuncture needles.

Electro-acupuncture treatment helps in decreasing blood lipids in patients with fatty liver disease and plays a significant role in improving the immunity system in patients with hepatitis in addition to improving their clinical symptoms. Previous clinical studies in China indicated that electro-acupuncture able to decrease total cholesterol (TC), triglycerides (TG), low-density lipoproteins (LDL), and elevate high-density lipoproteins (HDL) in patients suffering from dyslipidemia.

Interventions

  • Drug Medical treatment
    All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks.
  • Other Hypocaloric diet
    All women in both groups will be instructed to follow the same hypocaloric diet, as prescribed by a certified nutrition specialist, with a daily caloric intake of 1,200 kcal for a duration of 12 weeks.
  • Other Electroacupuncture
    Women in the experimental group only will undergo electroacupuncture three times per week for 12 weeks. Treatment will be delivered in the supine position using sterile needles inserted at eight standardized acupoints associated with central obesity and weight regulation, with insertion depths of 10-25 mm. Low-frequency electrical stimulation (2 Hz, 0.5 ms) will be applied to the abdominal region for 30 minutes per session.

Primary outcome measures

  • Body Mass Index (BMI) [Time frame: 12 weeks]
  • Waist Circumference [Time frame: 12 weeks]
  • Hip Circumference [Time frame: 12 weeks]
  • Waist-to-Hip Ratio (WHR) [Time frame: 12 weeks]
  • Serum Glutamic-Oxaloacetic Transaminase (SGOT / AST) [Time frame: 12 weeks]
  • Serum Glutamic-Pyruvic Transaminase (SGPT / ALT) [Time frame: 12 weeks]
Secondary outcome measures (4)
  • Total Cholesterol (TC) [Time frame: 12 weeks]
  • Triglycerides (TG) [Time frame: 12 weeks]
  • Low-Density Lipoprotein Cholesterol (LDL) [Time frame: 12 weeks]
  • High-Density Lipoprotein Cholesterol (HDL) [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Their ages will be ranged between 50 and 60 years old.
  • Their body mass index will be ranged from 30-40 kg/m2.
  • SGOT more 40 U/L.
  • SGPT more 40 U/L.
  • Waist/Hip Ratio more 1 cm.
  • Triglyceride more 150 mg/dl.
  • Cholesterol more 200 mg/dl.
  • LDL more 100 mg/dl.
  • HDL less 40 mg/dl.

Exclusion criteria

  • Cancer.
  • Concomitant cardiovascular disorders.
  • Respiratory, renal and liver dysfunction.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Aga Central Hospital — Aga

Identifiers

NCT: NCT07437001 · P.T.REC/012/005973

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗