A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty LiverPhase 4NCT06188611
A Phase IV Study of Huazhi Rougan Granule
A Phase 4 study of A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2017to 8 Nov 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 and≤65 years old;
- Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;
- Liver-to-spleen CT ratio ≤ 0.8; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver; ④ Voluntarily sign informed consent. The legal representative can sign informed consent on behalf of the patient who are unable to sign； ⑤ FPG≤7.0mmol/L 、HbA1c≤6.5%；ALT、AST、TBil≤2×ULN.
Who cannot join
- Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;；
- Severe fatty liver with ascites, edema, hyponatremia, hypokalemia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;；
- Those who had used any Chinese or Western drugs for the treatment of simple fatty liver within one month before randomization；
- Pregnant or lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;；
- Patients with serious primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, tumors, AIDS and other serious diseases that affect survival. For example: abnormal kidney function: creatinine higher than the upper limit of normal; Abnormal liver function: γ-GT>200U/L or ALT >2×ULN or AST>2×ULN; A clinically significant arrhythmia；
- ⑥ According to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：TC≥6.99mmol/L（270mg/dl）or LDL-C≥4.92mmol/L（190mg/dl）；
Show all 11Show fewer
- ⑦ Persons without or with limited capacity for civil conduct；
- ⑧ Those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse；
- ⑨ Allergic to the components of this drug；
- ⑩ Those who participated in other clinical investigators within 3 months prior to screening；
- ⑪ The investigators consider she/he inappropriate to participate in this study。
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai
About this study
Official title: A Placebo Control, Randomized, Double-blind, Multicenter Phase IV Study to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver (Damp-heat Obstruction Syndrome: Shi-Re-Zhong-Zu Zheng)
A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng)
- Being tested
- Huazhi Rougan Granule Placebo granule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huazhi Rougan Granule Placebo granuleDrug
Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule
| Study group | Role | What they receive |
|---|---|---|
| Huazhi Rougan granule | Experimental | Take with boiling water ,3 times a day, for 24 weeks; Receives: Drug: Huazhi Rougan Granule Placebo granule |
| Placebo granule | Placebo comparator | Take with boiling water ,3 times a day, for 24 weeks; Receives: Drug: Huazhi Rougan Granule Placebo granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver-to-spleen CT ratio
Measured: week 24
Secondary outcomes (3)
Laboratory test index:Traditional Chinese medicine (TCM) syndrome points
Measured: week 24
TG、ALT、AST、γ-GT、TBIL、HOMA-IR
Measured: week 24
AE、SAE
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start18 May 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty LiverStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188611
- Sponsor's protocol ID
- NTPC-HZRG-V1
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Control, Randomized, Double-blind, Multicenter Phase IV Study to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver (Damp-heat Obstruction Syndrome: Shi-Re-Zhong-Zu Zheng)
- ClinicalTrials.gov ID
- NCT06188611
- Acronym / sponsor ID
- NTPC-HZRG-V1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 3 Jan 2024 (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.
A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huazhi Rougan granule | Experimental | Drug: Huazhi Rougan Granule Placebo granuleTake with boiling water ,3 times a day, for 24 weeks; |
| Placebo granule | Placebo comparator | Drug: Huazhi Rougan Granule Placebo granuleTake with boiling water ,3 times a day, for 24 weeks; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 and≤65 years old;
Key exclusion criteria (11 listed)
- Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;；
- ⑥ According to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：TC≥6.99mmol/L（270mg/dl）or LDL-C≥4.92mmol/L（190mg/dl）；
- ⑦ Persons without or with limited capacity for civil conduct；
- ⑧ Those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse；
- ⑨ Allergic to the components of this drug；
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 |
|---|---|---|
| Huazhi Rougan Granule Placebo granuleExperimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule | Drug | Huazhi Rougan granule, Placebo granule |
Primary outcome
Liver-to-spleen CT ratio
Time frame: week 24
3 secondary outcomes
Laboratory test index:Traditional Chinese medicine (TCM) syndrome points
Time frame: week 24
TG、ALT、AST、γ-GT、TBIL、HOMA-IR
Time frame: week 24
AE、SAE
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver, run by Shandong New Time Pharmaceutical Co., LTD 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 3 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver-to-spleen CT ratio (time frame: week 24). 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 3 Jan 2024.