Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of Xian-Hua-Cha for Improving Hyperlipidemia Among Obese Population: a Crossover Trial

Conditions
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Hyperlipidemias, Obesity, Body Fat Disorder

Intervention / Treatment
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* Drug: Xian-Hua-Cha


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≧ 27kg/m2 Total cholesterol > 200 mg/dL or LDL > 130 mg/dL or triglyceride > 150 mg/dL Age ≧ 20 years and < 75 years No recognition difficulties Willing to sign inform consent and comply to protocol Exclusion Criteria: Pregnant or breast-feeding women Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder) Diagnosis of neurologic or psychiatric diseases Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR < 60 mL/min/1.73 m2) Acute stress condition (severe infection, receive major surgery in the recent 1 month) Vision, or hearing impairment With other clinical trial medication With medication for obesity or hyperlipidemia in the recent 1 month Heavy smoker, alcoholism or substance abuse Severe organ dysfunction: malignancies, autoimmune diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All eligible subjects will be allocated randomly to 2 groups. Each group will have a 7-month course, including 3-month XHC treatment and 3-month no XHC treatment period (control). One month washout period will be arranged between these two 3-month treatment periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xian-Hua-Cha (XHC) group<br>Xian-Hua-Cha (XHC) 520 mL, twice a day will be given with diet education/monitoring program for this group for 3 months, followed by one-month wash-out period and a 3-month period with diet education/monitor program alone. | Drug: Xian-Hua-Cha<br>* Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water<br>* Other names: XHC;|
| No Intervention: Control group<br>Diet education/monitoring program (500 kcal lower than estimated total energy expenditure of each subject) will be given to each subject for 3 months first, followed by one month wash-out period and a 3-month period of Xian-Hua-Cha (XHC) 520 mL, twice a day, intervention course. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on serum lipid profile | The changes on serum triglyceride, total cholesterol, LDL (low-density lipoprotein) cholesterol, and HDL (high-density lipoprotein) cholesterol. | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on body weight | The changes on body weight and body mass index (BMI) | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | 
| Changes on body fat composition | The changes on percentage of body fat and visceral fat, waist to hip ratio, and waistline. | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese herbal medicine, Xian-Hua-Cha, hyperlipidemia, obesity, body fat