HyperlipidemiasPhase 3NCT05632068
Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity
A Phase 3 study testing Xian-Hua-Cha in people with Hyperlipidemias and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Obesity, Body Fat Disorder
- What is being tested?
- Xian-Hua-Cha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Dec 2022to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou and Taoyuan branch
Taoyuan, 333
Hsing-Yu Chen, MD, +886-975366119, b8705016@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperlipidemias, Obesity, Body Fat Disorder
- Being tested
- Xian-Hua-Cha
- Keywords
- Chinese herbal medicine, Xian-Hua-Cha, hyperlipidemia, obesity, body fat
- Medical subject headings
- Hyperlipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xian-Hua-ChaDrug
Also called XHC
Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on serum lipid profile
The changes on serum triglyceride, total cholesterol, LDL (low-density lipoprotein) cholesterol, and HDL (high-density lipoprotein) cholesterol.
Measured: 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
The changes on body weight and body mass index (BMI)
Measured: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
Changes on body fat composition
The changes on percentage of body fat and visceral fat, waist to hip ratio, and waistline.
Measured: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start13 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632068
- Sponsor's protocol ID
- KMRPC5M001
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 34055005Liao 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.
PubMed 36160410
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Xian-Hua-Cha for Improving Hyperlipidemia Among Obese Population: a Crossover Trial
- ClinicalTrials.gov ID
- NCT05632068
- Acronym / sponsor ID
- KMRPC5M001
- Conditions
- Hyperlipidemias, Obesity, Body Fat Disorder
- Keywords
- Chinese herbal medicine, Xian-Hua-Cha, hyperlipidemia, obesity, body fat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Xian-Hua-Cha (XHC) group | Experimental | Drug: Xian-Hua-ChaXian-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. |
| 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xian-Hua-ChaAlso: XHCZizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water | Drug | Xian-Hua-Cha (XHC) group |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 34055005Hou 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.
- Background: PubMed 36160410Liao 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Gung Memorial Hospital, Linkou and Taoyuan branch
Taoyuan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xian-Hua-Cha in people with Hyperlipidemias and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05632068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.