Nonalcoholic Fatty Liver DiseaseNCT03375580
Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD
A study testing TLC, metformin and Compound Zhenzhu Tiaozhi capsule in people with Nonalcoholic Fatty Liver Disease, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 1 site in China.
Trial summary
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- TLC, metformin and Compound Zhenzhu Tiaozhi capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2017to 31 Dec 2019
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal
Who cannot join
- other chronic liver diseases serious complications in other organs malignant tumors
Trial locations and contacts
1 site in 1 country.
Xingxiang He, Dr. contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
Guobiao Huang, 86-20-39352064, 153706227@qq.com
About this study
Official title: Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.
Read the detailed description
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey [SF-36]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- TLC, metformin, Compound Zhenzhu Tiaozhi capsule, Simvastatin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLCDietary supplement
transform life custom (TLC)
metforminDrug
0.5g metformin group，PO tid
Compound Zhenzhu Tiaozhi capsuleDrug
Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.
SimvastatinDrug
20mg simvastatin, PO qn
| Study group | Role | What they receive |
|---|---|---|
| TLC group | Placebo comparator | transform life custom (TLC) group Receives: Dietary Supplement: TLC |
| TLC + metformin group | Active comparator | transform life custom (TLC) combined with 0.5g metformin, PO tid Receives: Dietary Supplement: TLC; Drug: metformin |
| TLC + CZT capsules group | Experimental | transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid Receives: Dietary Supplement: TLC; Drug: Compound Zhenzhu Tiaozhi capsule |
| TLC + simvastatin group | Active comparator | transform life custom (TLC) combined with 20mg simvastatin, PO qn Receives: Dietary Supplement: TLC; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat attenuation index
The fat attenuation index will be used to assess the therapeutic efficacy. A normal fat attenuation index is defined as < 240 db/m, mild is 240-264 db/m, moderate is 265-294 db/m, and severity is > 295 db/m.We will detect the fat attenuation index at 6 months following treatment. Effective: fat attenuation index is reduced by a level or more (example: moderate to mild). Invalid: fails to meet the effective standard.
Measured: at 6 months following therapy
Secondary outcomes (5)
Serum triglyceride
detecting the serum level of triglyceride
Measured: at 6 months following therapy
Serum cholesterol
detecting the serum level of cholesterol
Measured: at 6 months following therapy
Serum lipoproteins
including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).
Measured: at 6 months following therapy
Hydrogen/methane breath testing
breath testing for SIBO
Measured: at 6 months following therapy
Quality of life
The quality of life of the patients before and after treatment will be assessed using the 36-Item Short Form Health Survey and compared to assess the improvement.
Measured: at 6 months following therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start31 Dec 2017 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Xingxiang, The First Affiliated Hospital of Guangdong Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375580
- Sponsor's protocol ID
- U1111-1201-8245
- Status last verified
- Dec 2017
- First submitted
- 26 Nov 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03375580
- Acronym / sponsor ID
- U1111-1201-8245
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2017 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Dec 2017 (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.
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.
Detailed description
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey [SF-36]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TLC group | Placebo comparator | Dietary Supplement: TLCtransform life custom (TLC) group |
| TLC + metformin group | Active comparator | Dietary Supplement: TLC, Drug: metformintransform life custom (TLC) combined with 0.5g metformin, PO tid |
| TLC + CZT capsules group | Experimental | Dietary Supplement: TLC, Drug: Compound Zhenzhu Tiaozhi capsuletransform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid |
| TLC + simvastatin group | Active comparator | Dietary Supplement: TLC, Drug: Simvastatintransform life custom (TLC) combined with 20mg simvastatin, PO qn |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal
Key exclusion criteria (1 listed)
- other chronic liver diseases serious complications in other organs malignant tumors
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 |
|---|---|---|
| TLCtransform life custom (TLC) | Dietary supplement | TLC + CZT capsules group, TLC + metformin group, TLC + simvastatin group, TLC group |
| metformin0.5g metformin group，PO tid | Drug | TLC + metformin group |
| Compound Zhenzhu Tiaozhi capsuleCompound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus. | Drug | TLC + CZT capsules group |
| Simvastatin20mg simvastatin, PO qn | Drug | TLC + simvastatin group |
Primary outcome
Fat attenuation index
Time frame: at 6 months following therapy
The fat attenuation index will be used to assess the therapeutic efficacy. A normal fat attenuation index is defined as < 240 db/m, mild is 240-264 db/m, moderate is 265-294 db/m, and severity is > 295 db/m.We will detect the fat attenuation index at 6 months following treatment. Effective: fat attenuation index is reduced by a level or more (example: moderate to mild). Invalid: fails to meet the effective standard.
5 secondary outcomes
Serum triglyceride
Time frame: at 6 months following therapy
Serum cholesterol
Time frame: at 6 months following therapy
Serum lipoproteins
Time frame: at 6 months following therapy
Hydrogen/methane breath testing
Time frame: at 6 months following therapy
Quality of life
Time frame: at 6 months following therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Nonalcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Xingxiang He, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLC, metformin and Compound Zhenzhu Tiaozhi capsule in people with Nonalcoholic Fatty Liver Disease, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 1 site in China.
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 1 inclusion and 1 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 19 Dec 2017. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Xingxiang He, Dr. (hexingxiangtongxun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat attenuation index (time frame: at 6 months following therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.