Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

October 4, 2024 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital, Linkou and Taoyuan branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xian-Hua-Cha (XHC) group
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
Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water
Other Names:
  • XHC
No Intervention: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on serum lipid profile
Time Frame: 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.
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
Time Frame: 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)
1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
Changes on body fat composition
Time Frame: 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.
1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hsing-Yu Chen, MD, Chang Gung Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMRPC5M001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing IPD is based on request, and the release of IPD must be approved by the Institutional Review Board of the Chang Gung Medical Foundation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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