Efficacy and SafetyPhase 4NCT06202456

A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver

A Phase 4 study testing Huazhi Rougan granule in people with Efficacy and Safety, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Efficacy and Safety
What is being tested?: Huazhi Rougan granule
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,007 participants
Where: 1 siteChina
Study dates: 13 May 2020to 9 Jun 2022
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 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;
Voluntarily sign informed consent;
Liver-to-spleen CT ratio < 1.0; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver;
HbA1c≤6.5%；ALT、AST、TBil≤2×ULN；GFR≥60（ml/min/1.73m2）.

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 and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;
Pregnant and 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;；
Patient with serious primary cardiovascular disease, kidney disease and other serious diseases that affect survival;
Patient with a history of cancer;
Patient with HCV antibody, HIV antibody positive or HBsAg positive and HBV-DNA titer positive;

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Have a history of alcohol abuse (alcohol equivalent male≥30g/d, female ≥20g/d) or drug abuse；
Allergic to the components of this drug；；
Those who participated in other clinical investigators within 3 months prior to screening;
Those who with a history of diabetes；
Patients who had used the same traditional Chinese medicine for the treatment of non-alcoholic simple fatty liver within 2 weeks before screening (except experimental drugs);
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

Other trials in China

About this study

Official title: A Single-arm, 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)

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period

Conditions: Efficacy and Safety
Being tested: Huazhi Rougan granule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Huazhi Rougan granuleDrug
Huazhi Rougan granule

Study groups in NCT06202456
Study group	Role	What they receive
Huazhi Rougan granule	Experimental	Not described Receives: Drug: Huazhi Rougan granule

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver-to-spleen CT ratio
Clinical recovery: liver/spleen CT ratio ≥ 1; Obvious effect: liver/spleen CT ratio decreased by 2 grades (severe → mild); Effective: Liver/spleen CT ratio decreased by 1 grade (severe → moderate, or moderate → mild) :+ Ineffective: liver/spleen CT ratio did not change or even increased.
Measured: 12 weeks

Secondary outcomes (3)

The reduction of traditional Chinese medicine (TCM) syndrome integral
Clinical recovery: syndrome integral decreased ≥ 95%; Obvious Effective:70%≤the reduction of syndrome integral <95%; Effective :30%≤the reduction of syndrome score <70%; Ineffective: less than 30% reduction in syndrome integral. note: The reduction of TCM syndrome integral (%) = (Pre-treatment integral - post-treatment integral)/Pre-treatment integralx 100%
Measured: 12 weeks
the reduction of ALT
Clinical control: Liver enzymology (ALT) returned to normal; + Obvious effect: liver enzyme (ALT) index decreased by ≥50%; Effective: Liver enzyme (ALT) index decreased <50% but≥ 30%; Ineffective: Liver enzyme (ALT) index decreased <30%。
Measured: 12 weeks
the reduction of blood lipid index
blood lipid index including TC、TG、and HDL-C
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20209 Jun 2022

First posted11 Jan 2024
Study start13 May 2020
Primary completion9 Jun 2022
Study completion9 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Efficacy and SafetyStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,007 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06202456
Sponsor's protocol ID: NTP-HZRG-G-IV
Status last verified: Jan 2024
First submitted: 13 Dec 2023
Last updated: 11 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, 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: NCT06202456
Acronym / sponsor ID: NTP-HZRG-G-IV
Conditions: Efficacy and Safety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,007 participants (actual)
Lead sponsor: Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
Study start: 13 May 2020 (actual)
Primary completion: 9 Jun 2022 (actual)
Study completion: 9 Jun 2022 (actual)
First posted: 11 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.

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Huazhi Rougan granule	Experimental	Drug: Huazhi Rougan granule

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 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;
Voluntarily sign informed consent;
Liver-to-spleen CT ratio < 1.0; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver;
HbA1c≤6.5%；ALT、AST、TBil≤2×ULN；GFR≥60（ml/min/1.73m2）.

Key exclusion criteria (12 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;
Severe fatty liver with ascites, edema, hyponatremia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;
Pregnant and 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;；
Patient with serious primary cardiovascular disease, kidney disease and other serious diseases that affect survival;
Patient with a history of cancer;

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 granuleHuazhi Rougan granule	Drug	Huazhi Rougan granule

Primary outcome

Liver-to-spleen CT ratio
Time frame: 12 weeks
Clinical recovery: liver/spleen CT ratio ≥ 1; Obvious effect: liver/spleen CT ratio decreased by 2 grades (severe → mild); Effective: Liver/spleen CT ratio decreased by 1 grade (severe → moderate, or moderate → mild) :+ Ineffective: liver/spleen CT ratio did not change or even increased.

3 secondary outcomes

The reduction of traditional Chinese medicine (TCM) syndrome integral
Time frame: 12 weeks
the reduction of ALT
Time frame: 12 weeks
the reduction of blood lipid index
Time frame: 12 weeks

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 11 Jan 2024.
Individual participant dataSharing planned: Undecided

Related trials for Efficacy and Safety

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Recruiting
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Anastomotic Leaks, Hartmanns Stump Leakage
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Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
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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.

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 testing Huazhi Rougan granule in people with Efficacy and Safety, 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 5 inclusion and 12 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 11 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. 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: 12 weeks). 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 NCT06202456.

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 11 Jan 2024.