Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

NCT05632068 | Unknown Phase 3

• 1 other identifier: KMRPC5M001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias; Obesity; Body Fat Disorder

Keywords

Chinese herbal medicine; Xian-Hua-Cha; hyperlipidemia; obesity; body fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes on body weight

  1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)

• Changes on body fat composition

  1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)

Study Arms (2)

Xian-Hua-Cha (XHC) group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Xian-Hua-Cha DRUG

Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water

Also known as: XHC

Xian-Hua-Cha (XHC) group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou and Taoyuan branch

Taoyuan District, 333, Taiwan

RECRUITING

Related 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.

  PMID: 34055005 BACKGROUND

• 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.

  PMID: 36160410 BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias; Obesity

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A number generated by random sequence before enrollment will be assigned to each subject to separate all subjects to two groups. Diet education/monitoring will be given with or without XHC depending the phase of trial course. Since XHC is a mixture of herbal products and difficult to make proper placebo, we adopt the crossover with open-label design in this study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: December 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)