Posthepatitic CirrhosisPhase 4NCT00543426
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
A Phase 4 study testing Fuzheng Huayu Tablets in people with Posthepatitic Cirrhosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posthepatitic Cirrhosis
- What is being tested?
- Fuzheng Huayu Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2007to Jun 2009
- 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
- Clinical diagnosis of B Post hepatitic cirrhosis.
- Male or female patients between 18~65 years old.
- Written informed consent.
Who cannot join
- Child-Pugh C above 12, or ALT > 2×ULN, TBiL > 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer.
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Deformed man by the law.
- Pregnancy or breast feeding women, or unwilling to have contraception.
- Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
- Enter other trials lately one month.
- Other cause of cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).
The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.
- Conditions
- Posthepatitic Cirrhosis
- Being tested
- Fuzheng Huayu Tablets, sham Fuzheng Huayu Tablets (placebo)
- Keywords
- Fuzheng Huayu Tablets, Multicenter clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Huayu TabletsDrug
Tablet,three times a day,four tablets one time
sham Fuzheng Huayu Tablets (placebo)Drug
Tablet, three times a day, four tablets one time
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fuzheng Huayu Tablets Receives: Drug: Fuzheng Huayu Tablets |
| 2 | Sham comparator | sham Fuzheng Huayu Tablets Receives: Drug: sham Fuzheng Huayu Tablets (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Measured: six months
Secondary outcomes (1)
hepatic function; blood test; blood ammonia and blood sugar determination
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posthepatitic CirrhosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zengzeng Cai, Ph.D, Study director, Shanghai Univercity of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543426
- Sponsor's protocol ID
- 06DZ19728
- Status last verified
- Jun 2009
- First submitted
- 12 Oct 2007
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao CQ, Wu YQ, Xu LM. [Curative effects of Fuzheng Huayu capsules on hepatic fibrosis and the functional mechanisms: a review]. Zhong Xi Yi Jie He Xue Bao. 2006 Sep;4(5):467-72. doi: 10.3736/jcim20060505. Chinese.
PubMed 16965738Liu P, Hu YY, Liu C, Xu LM, Liu CH, Sun KW, Hu DC, Yin YK, Zhou XQ, Wan MB, Cai X, Zhang ZQ, Ye J, Tang BZ, He J. [Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B]. Zhong Xi Yi Jie He Xue Bao. 2003 Jul;1(2):89-98, 102. doi: 10.3736/jcim20030204. Chinese.
PubMed 15339577Zhang Q, Zhang WT, Wei JJ, Wang XB, Liu P. [Combined use of factor analysis and cluster analysis in classification of traditional Chinese medical syndromes in patients with posthepatitic cirrhosis]. Zhong Xi Yi Jie He Xue Bao. 2005 Jan;3(1):14-8. doi: 10.3736/jcim20050105. Chinese.
PubMed 15644152
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
- ClinicalTrials.gov ID
- NCT00543426
- Acronym / sponsor ID
- 06DZ19728
- Conditions
- Posthepatitic Cirrhosis
- Keywords
- Fuzheng Huayu Tablets, Multicenter clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Oct 2007 (estimated)
- 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.
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).
The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.
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 |
|---|---|---|
| 1 | Experimental | Drug: Fuzheng Huayu TabletsFuzheng Huayu Tablets |
| 2 | Sham comparator | Drug: sham Fuzheng Huayu Tablets (placebo)sham Fuzheng Huayu Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of B Post hepatitic cirrhosis.
- Male or female patients between 18~65 years old.
- Written informed consent.
Key exclusion criteria (7 listed)
- Child-Pugh C above 12, or ALT > 2×ULN, TBiL > 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer.
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Deformed man by the law.
- Pregnancy or breast feeding women, or unwilling to have contraception.
- Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
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 |
|---|---|---|
| Fuzheng Huayu TabletsTablet,three times a day,four tablets one time | Drug | 1 |
| sham Fuzheng Huayu Tablets (placebo)Tablet, three times a day, four tablets one time | Drug | 2 |
Primary outcome
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
Time frame: six months
1 secondary outcome
hepatic function; blood test; blood ammonia and blood sugar determination
Time frame: six months
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 7 Mar 2013.
- Background: PubMed 16965738Zhao CQ, Wu YQ, Xu LM. [Curative effects of Fuzheng Huayu capsules on hepatic fibrosis and the functional mechanisms: a review]. Zhong Xi Yi Jie He Xue Bao. 2006 Sep;4(5):467-72. doi: 10.3736/jcim20060505. Chinese.
- Background: PubMed 15339577Liu P, Hu YY, Liu C, Xu LM, Liu CH, Sun KW, Hu DC, Yin YK, Zhou XQ, Wan MB, Cai X, Zhang ZQ, Ye J, Tang BZ, He J. [Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B]. Zhong Xi Yi Jie He Xue Bao. 2003 Jul;1(2):89-98, 102. doi: 10.3736/jcim20030204. Chinese.
- Background: PubMed 15644152Zhang Q, Zhang WT, Wei JJ, Wang XB, Liu P. [Combined use of factor analysis and cluster analysis in classification of traditional Chinese medical syndromes in patients with posthepatitic cirrhosis]. Zhong Xi Yi Jie He Xue Bao. 2005 Jan;3(1):14-8. doi: 10.3736/jcim20050105. Chinese.
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.
Zengzeng Cai, Ph.D study director
Shanghai Univercity of TCM
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 Fuzheng Huayu Tablets in people with Posthepatitic Cirrhosis, run by Shanghai University of Traditional Chinese Medicine 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 7 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 7 Mar 2013. 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?
the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis (time frame: six months). 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 NCT00543426, which also lists 3 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 7 Mar 2013.