Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632068
• Other study ID #: KMRPC5M001
• Status: Recruiting
• Phase: Phase 3
• Start date: December 13, 2022
• Est. completion date: October 5, 2024

Study information

• Verified date: November 2022
• Source: Chang Gung Memorial Hospital
• Contact: Hsing-Yu Chen, MD
• Phone: +886-975366119
• Email: b8705016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 5, 2024
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

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

Related Conditions & MeSH terms

• Body Fat Disorder
• Hyperlipidemias
• Hyperlipoproteinemias
• Obesity

Intervention

Drug:
• Xian-Hua-Cha
Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou and Taoyuan branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)