Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05632068

Collaborator

(none)

100

Enrollment

Arms

22.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias Obesity Body Fat Disorder	Drug: Xian-Hua-Cha	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

May 19, 2024

Anticipated Study Completion Date :

Oct 5, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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