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Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

Recruiting
20 - 75 years of age
Both
Phase 3

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Overview

In the past decades, lipid and body fat disorders become a serious global healthcare issue, especially among the obese population. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to explore the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among obese patient. For this purpose, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are analyzed in the end of this study.

Description

Recently, there are more and more studies show the natural herbal products can improve obesity and related metabolic disorders through changing the body composition and even body weight, but most of the studies are still at the phase of animal studies.

In the ancient Chinese medical book Danxi's mastery of medicine mentioned "Overweight people often have phlegm." From the past observational study, obesity is related phlegm, and the recent concept shows that obesity is a chronic inflammation disease. Therefore, we combined phlegm removal herbal medicine and Chinese medicine for clearing heat and detoxifying together for obese patients with lipid disorders in clinical practice. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to analyze the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among the obese population. For this reason, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are collected for analysis. Besides, we also record adverse effects from taking XHC to assess the safety of XHC.

Eligibility

Inclusion Criteria:

  1. BMI ≧ 27kg/m2
  2. Total cholesterol > 200 mg/dL or LDL > 130 mg/dL or triglyceride > 150 mg/dL
  3. Age ≧ 20 years and < 75 years
  4. No recognition difficulties
  5. Willing to sign inform consent and comply to protocol

Exclusion Criteria:

  1. Pregnant or breast-feeding women
  2. Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder)
  3. Diagnosis of neurologic or psychiatric diseases
  4. Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR < 60 mL/min/1.73 m2)
  5. Acute stress condition (severe infection, receive major surgery in the recent 1 month)
  6. Vision, or hearing impairment
  7. With other clinical trial medication
  8. With medication for obesity or hyperlipidemia in the recent 1 month
  9. Heavy smoker, alcoholism or substance abuse
  10. Severe organ dysfunction: malignancies, autoimmune diseases

Study details

Hyperlipidemias, Obesity, Body Fat Disorder

NCT05632068

Chang Gung Memorial Hospital

25 January 2024

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