PsoriasisNCT02191020
Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis
A study testing Total glucosides of paeony & Acitretin Capsules and Acitretin Capsules in people with Psoriasis, run by Xijing Hospital at 1 site in China.
Trial summary
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Total glucosides of paeony & Acitretin Capsules and Acitretin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Oct 2013
- Phase
- Interventional
- 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
- Diagnosed according to Classification criteria for Psoriasis vulgaris;
- Patients aged 18 to 65 years (to the date of screening);
- PASI grade>7point<20 point;
- Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
- Understanding the whole process of the study, voluntary participation and signed the informed consent;
- Patient compliance is good, can guarantee in course of observation.
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- Exclusion Criteria:One of the following is not included in this study:
- Pregnant women, ready to pregnant or lactating women;
- Known to root of herbaceous peony total glycosides (TGP) drug allergy;
- Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
- Need insulin control of diabetes; High blood pressure did not get good controller ;
- Patients with white blood cells <4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets <100 × 109 / L, or other blood disease;
- Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
- Patients suffering from malignant tumor;
- Patients suffering from acute and chronic infectious diseases;
- Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other cases which researchers believe that can not enroll.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
- Conditions
- Psoriasis
- Being tested
- Total glucosides of paeony & Acitretin Capsules, Acitretin Capsules
- Keywords
- Total Glucosides of Paeony(TGP), Acitretin Capsules, Psoriasis Vulgaris
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total glucosides of paeony & Acitretin CapsulesDrug
Acitretin CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Total glucosides of paeony & Acitretin Capsules | Experimental | During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d Receives: Drug: Total glucosides of paeony & Acitretin Capsules |
| Acitretin Capsules | Active comparator | 20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral. Receives: Drug: Acitretin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Psoriasis Area and Severity Index
After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P<0.05).
Measured: week 0 and week 12
Secondary outcomes (1)
incidence of elevated Alanine aminotransferase
After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P<0.05).
Measured: week 0 and week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University
- Responsible party
- Principal investigator, xjpfW, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191020
- Sponsor's protocol ID
- XijingH-PF-20120909
- Status last verified
- Jul 2014
- First submitted
- 8 Jan 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02191020
- Acronym / sponsor ID
- XijingH-PF-20120909
- Conditions
- Psoriasis
- Keywords
- Total Glucosides of Paeony(TGP), Acitretin Capsules, Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2014 (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.
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total glucosides of paeony & Acitretin Capsules | Experimental | Drug: Total glucosides of paeony & Acitretin CapsulesDuring the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d |
| Acitretin Capsules | Active comparator | Drug: Acitretin Capsules20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosed according to Classification criteria for Psoriasis vulgaris;
- Patients aged 18 to 65 years (to the date of screening);
- PASI grade>7point<20 point;
- Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
- Understanding the whole process of the study, voluntary participation and signed the informed consent;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Total glucosides of paeony & Acitretin Capsules | Drug | Total glucosides of paeony & Acitretin Capsules |
| Acitretin Capsules | Drug | Acitretin Capsules |
Primary outcome
Reduction in Psoriasis Area and Severity Index
Time frame: week 0 and week 12
After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P<0.05).
1 secondary outcome
incidence of elevated Alanine aminotransferase
Time frame: week 0 and week12
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 15 Jul 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 study testing Total glucosides of paeony & Acitretin Capsules and Acitretin Capsules in people with Psoriasis, run by Xijing Hospital 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 17 inclusion and 0 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 15 Jul 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 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.
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?
Reduction in Psoriasis Area and Severity Index (time frame: week 0 and week 12). 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 15 Jul 2014.