Clinical trial NCT05632068: Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity
Official title: The Efficacy of Xian-Hua-Cha for Improving Hyperlipidemia Among Obese Population: a Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperlipidemias
Obesity
Body Fat Disorder
Keywords: Chinese herbal medicine
Xian-Hua-Cha
hyperlipidemia
obesity
body fat
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes on serum lipid profile
timeFrame: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
Secondary outcomes:
measure: Changes on body weight
timeFrame: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
measure: Changes on body fat composition
timeFrame: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou and Taoyuan branch
Study officials:
References:
citation: Hou HI, Chen HY, Lu JJ, Chang SC, Li HY, Jiang KH, Chen JL. The Relationships between Leptin, Genotype, and Chinese Medicine Body Constitution for Obesity. Evid Based Complement Alternat Med. 2021 May 7;2021:5510552. doi: 10.1155/2021/5510552. eCollection 2021.
citation: Liao YN, Chen HY, Yang CW, Lee PW, Hsu CY, Huang YT, Yang TH. Chinese herbal medicine is associated with higher body weight reduction than liraglutide among the obese population: A real-world comparative cohort study. Front Pharmacol. 2022 Sep 9;13:978814. doi: 10.3389/fphar.2022.978814. eCollection 2022.