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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Medical treatment
  All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Body Mass Index (BMI) [Срок оценки: 12 weeks]
• Waist Circumference [Срок оценки: 12 weeks]
• Hip Circumference [Срок оценки: 12 weeks]
• Waist-to-Hip Ratio (WHR) [Срок оценки: 12 weeks]
• Serum Glutamic-Oxaloacetic Transaminase (SGOT / AST) [Срок оценки: 12 weeks]
• Serum Glutamic-Pyruvic Transaminase (SGPT / ALT) [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• Total Cholesterol (TC) [Срок оценки: 12 weeks]
• Triglycerides (TG) [Срок оценки: 12 weeks]
• Low-Density Lipoprotein Cholesterol (LDL) [Срок оценки: 12 weeks]
• High-Density Lipoprotein Cholesterol (HDL) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Aga Central Hospital — Aga

Идентификаторы

NCT: NCT07437001 · P.T.REC/012/005973

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗