Liver FunctionPhase 2/3NCT01708733
The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function
A Phase 2/3 study testing KSY in people with Liver Function, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Function
- What is being tested?
- KSY
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Mar 2014
- Phase
- Phase 2/3
- 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
- 40 < GPT <200 HCV carrier Age: 18-65 yrs old
Who cannot join
- Creatinine >2.0 mg/dL Total bilirubin > 2.0mg/dL Not suitable patients diagnosis by physician in charge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.
The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.
Read the detailed description
percentage of change on HCV RNA titer and liver function (GPT).
- Conditions
- Liver Function
- Being tested
- KSY
- Keywords
- HCV carrier, Chinese herbal medicine, Liver function, HCV RNA titer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSYDrug
Chinese herbal formula
| Study group | Role | What they receive |
|---|---|---|
| KSY diluted | Placebo comparator | KSY diluted, 100mg decoction by mouth per day for 6 weeks |
| KSY | Experimental | KSY, 100mg decoction by mouth per day for 6 weeks Receives: Drug: KSY |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA titer
Measured: 6 weeks
Secondary outcomes (1)
Serum GPT level
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FunctionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708733
- Sponsor's protocol ID
- 101001-62-010
- Status last verified
- May 2014
- First submitted
- 15 Oct 2012
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01708733
- Acronym / sponsor ID
- 101001-62-010
- Conditions
- Liver Function
- Keywords
- HCV carrier, Chinese herbal medicine, Liver function, HCV RNA titer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Oct 2012 (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 aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.
Detailed description
percentage of change on HCV RNA titer and liver function (GPT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KSY diluted | Placebo comparator | –KSY diluted, 100mg decoction by mouth per day for 6 weeks |
| KSY | Experimental | Drug: KSYKSY, 100mg decoction by mouth per day for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 < GPT <200 HCV carrier Age: 18-65 yrs old
Key exclusion criteria (1 listed)
- Creatinine >2.0 mg/dL Total bilirubin > 2.0mg/dL Not suitable patients diagnosis by physician in charge.
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 |
|---|---|---|
| KSYChinese herbal formula | Drug | KSY |
Primary outcome
HCV RNA titer
Time frame: 6 weeks
1 secondary outcome
Serum GPT level
Time frame: 6 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 29 May 2014.
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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 2/3 study testing KSY in people with Liver Function, run by Taipei City 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 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: finished, as of the sponsor's last update on 29 May 2014. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
HCV RNA titer (time frame: 6 weeks). 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 29 May 2014.