Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

Phase 3

Recruiting

• Conditions: Hyperlipidemias; Obesity; Body Fat Disorder
• Interventions: Drug: Xian-Hua-Cha

• Registration Number: NCT05632068
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Study Start: 2022-12-13
• Status Verified: 2023-11
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xian-Hua-Cha (XHC) group	Xian-Hua-Cha	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Linkou and Taoyuan branch; 🇨🇳 Taoyuan, Taiwan