Chronic Liver DiseasePhase 4NCT02347319
To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease
A Phase 4 study testing Pennel and Legalon in people with Chronic Liver Disease, run by PharmaKing at 1 site in South Korea.
Trial summary
Purpose To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Pennel and Legalon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Jun 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20years of age
- Patients with more 60 ALT in screening period.
- To evaluate ALT and AST at least three months.
- Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days
- Women of childbearing age get her consent for contraception, pregnancy urine test result negative.
Who cannot join
- ALT>10UNL on screening period.
- Current treatment on another clinical trial
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of korea, Bucheon ST. Mary's Hosipital
Bucheon-si, Gyeonggi-do, 420-717
About this study
Official title: A Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined With Garlic Oil in Patients With Transaminase Elevated Chronic Liver Disease
Purpose
- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.
Read the detailed description
Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.
- Conditions
- Chronic Liver Disease
- Being tested
- Pennel, Legalon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PennelDrug
Also called DDB/Garlic oil
Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid
LegalonDrug
Also called Silymarin
Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid
PlaceboDrug
Also called Lactose
Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid
| Study group | Role | What they receive |
|---|---|---|
| Pennel | Experimental | This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks. Receives: Drug: Pennel |
| Legalon | Active comparator | This group will treated with Silymarin 140mg for 12 weeks. Receives: Drug: Legalon |
| Placebo | Placebo comparator | This group will treated with Placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized rate in serum ALT
The rate of alanine aminotransferase (ALT) normalization
Measured: 12 weeks
Secondary outcomes (8)
ALT
Measured: 8, 12 weeks
AST
Measured: 8, 12 weeks
γ-GTP
Measured: 8, 12 weeks
AST/ALT ratio
Measured: 8, 12 weeks
ALP
Measured: 8, 12 weeks
Albumin
Measured: 8, 12 weeks
Total Bilirubin
Measured: 8, 12 weeks
The assessment of health-related quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347319
- Sponsor's protocol ID
- P2010-PN004
- Status last verified
- Jan 2015
- First submitted
- 11 Jun 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined With Garlic Oil in Patients With Transaminase Elevated Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02347319
- Acronym / sponsor ID
- P2010-PN004
- Conditions
- Chronic Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2015 (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.
Purpose
- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.
Detailed description
Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pennel | Experimental | Drug: PennelThis group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks. |
| Legalon | Active comparator | Drug: LegalonThis group will treated with Silymarin 140mg for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThis group will treated with Placebo for 12 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 20years of age
- Patients with more 60 ALT in screening period.
- To evaluate ALT and AST at least three months.
- Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days
- Women of childbearing age get her consent for contraception, pregnancy urine test result negative.
Key exclusion criteria (3 listed)
- ALT>10UNL on screening period.
- Current treatment on another clinical trial
- Pregnancy or breastfeeding
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 |
|---|---|---|
| PennelAlso: DDB/Garlic oilPennel 2 Tablet, Legalon Placebo 1 tablet, Tid | Drug | Pennel |
| LegalonAlso: SilymarinPennel Placebo 2 Tablet, Legalon 1 tablet, Tid | Drug | Legalon |
| PlaceboAlso: LactosePennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid | Drug | Placebo |
Primary outcome
Normalized rate in serum ALT
Time frame: 12 weeks
The rate of alanine aminotransferase (ALT) normalization
8 secondary outcomes
ALT
Time frame: 8, 12 weeks
AST
Time frame: 8, 12 weeks
γ-GTP
Time frame: 8, 12 weeks
AST/ALT ratio
Time frame: 8, 12 weeks
ALP
Time frame: 8, 12 weeks
Albumin
Time frame: 8, 12 weeks
Total Bilirubin
Time frame: 8, 12 weeks
The assessment of health-related quality of life
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 27 Jan 2015.
Related trials for Chronic Liver Disease
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
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 Pennel and Legalon in people with Chronic Liver Disease, run by PharmaKing at 1 site in South Korea.
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 3 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 27 Jan 2015. 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 South Korea. 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?
Normalized rate in serum ALT (time frame: 12 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 27 Jan 2015.