Liver DiseasesPhase 4NCT04718051
S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
A Phase 4 study testing Shen Pu Yang Gan Wan in people with Liver Diseases, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Shen Pu Yang Gan Wan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2021to 31 Dec 2021
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fatty liver diagnosed by abdominal ultrasound or hepatic fibrometer within half a year's data
- Subjects with the non-alcoholic fatty liver disease
- The severity of fatty liver should be at least 3 points by taking an abdominal ultrasound
Who cannot join
- Female patients are pregnant or breastfeeding.
- Patients with viral hepatitis.
- Long-term drinkers.
- Those who use slimming products and vitamin E.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wanfang Hospital
Taipei, Wenshan District, 116
Ming Shun Wu, 0229307930 ext. 1248, mswu@tmu.edu.tw
About this study
With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.
Read the detailed description
With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy. Moreover, drugs also have side effects, and there is currently no convenient and effective treatment for people who have non-alcoholic fatty liver disease. The purpose of this trial is that investigating and evaluating the effects on fatty liver, liver fiber, and metabolic indexes after subjects using Shen Pu Yang Gan Wan.
- Conditions
- Liver Diseases
- Being tested
- Shen Pu Yang Gan Wan, Placebo
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen Pu Yang Gan WanDrug
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
PlaceboDrug
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
| Study group | Role | What they receive |
|---|---|---|
| Shen Pu Yang Gan Wan | Experimental | Traditional Chinese Medicine Receives: Drug: Shen Pu Yang Gan Wan |
| Placebo Comparator | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AST index
Measure the changes in the index which is AST relate to Liver inflammation
Measured: 36 weeks
Change in ACT index
Measure the changes in the index which is ACT relate to Liver inflammation
Measured: 36 weeks
Change in HbA1c
Measure the changes in the index which is HbA1c relate to Liver inflammation
Measured: 36 weeks
Fibroscan
Measure the changes in the index which is Liver Fibrosis
Measured: 36 weeks
Secondary outcomes (1)
Measuring Body Mass Index
Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sheng Pu Pharmaceutics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ming Shun Wu, Study director, Taipei Municipal Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718051
- Sponsor's protocol ID
- N202007032
- Status last verified
- Dec 2020
- First submitted
- 18 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang MD, Chiang YM, Higashiyama R, Asahina K, Mann DA, Mann J, Wang CC, Tsukamoto H. Rosmarinic acid and baicalin epigenetically derepress peroxisomal proliferator-activated receptor gamma in hepatic stellate cells for their antifibrotic effect. Hepatology. 2012 Apr;55(4):1271-81. doi: 10.1002/hep.24792. Epub 2012 Mar 1.
PubMed 22095555
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04718051
- Acronym / sponsor ID
- N202007032
- Conditions
- Liver Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Collaborators
- Sheng Pu Pharmaceutics Co., Ltd.
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.
Detailed description
With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy. Moreover, drugs also have side effects, and there is currently no convenient and effective treatment for people who have non-alcoholic fatty liver disease. The purpose of this trial is that investigating and evaluating the effects on fatty liver, liver fiber, and metabolic indexes after subjects using Shen Pu Yang Gan Wan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shen Pu Yang Gan Wan | Experimental | Drug: Shen Pu Yang Gan WanTraditional Chinese Medicine |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo Comparator |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with fatty liver diagnosed by abdominal ultrasound or hepatic fibrometer within half a year's data
- Subjects with the non-alcoholic fatty liver disease
- The severity of fatty liver should be at least 3 points by taking an abdominal ultrasound
Key exclusion criteria (4 listed)
- Female patients are pregnant or breastfeeding.
- Patients with viral hepatitis.
- Long-term drinkers.
- Those who use slimming products and vitamin E.
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 |
|---|---|---|
| Shen Pu Yang Gan WanShen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose. | Drug | Shen Pu Yang Gan Wan |
| PlaceboShen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose. | Drug | Placebo Comparator |
Primary outcome
Change in AST index
Time frame: 36 weeks
Measure the changes in the index which is AST relate to Liver inflammation
Change in ACT index
Time frame: 36 weeks
Measure the changes in the index which is ACT relate to Liver inflammation
Change in HbA1c
Time frame: 36 weeks
Measure the changes in the index which is HbA1c relate to Liver inflammation
Fibroscan
Time frame: 36 weeks
Measure the changes in the index which is Liver Fibrosis
1 secondary outcome
Measuring Body Mass Index
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 22095555Yang MD, Chiang YM, Higashiyama R, Asahina K, Mann DA, Mann J, Wang CC, Tsukamoto H. Rosmarinic acid and baicalin epigenetically derepress peroxisomal proliferator-activated receptor gamma in hepatic stellate cells for their antifibrotic effect. Hepatology. 2012 Apr;55(4):1271-81. doi: 10.1002/hep.24792. Epub 2012 Mar 1.
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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.
Ming Shun Wu study director
Taipei Municipal Wanfang Hospital
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 Shen Pu Yang Gan Wan in people with Liver Diseases, run by Taipei Medical University WanFang 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 3 inclusion and 4 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 22 Jan 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Shun Wu, PHD (+886229307930, vw1017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AST index (time frame: 36 weeks). The study lists 4 primary outcomes in all. 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 NCT04718051, which also lists 1 linked publication.
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 22 Jan 2021.