Plaque PsoriasisNCT02153840
Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis
A study testing PSORI-CM01（YXBCM01） granule in people with Plaque Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 3 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Chinese herbal PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of Chinese Medicine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- PSORI-CM01（YXBCM01） granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2013to Oct 2015
- 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
- Stable plaque psoriasis, duration > 1 year.
- Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient.
- Mild psoriasis:3<PASI≤10, and BSA≤10%.
- Informed consent.
Who cannot join
- Guttate psoriasis, inverse psoriasis or exclusively involves the face;
- Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis.
- Pregnant, lactating, or which one plan to become pregnant in a year;
- SAS（Self-rating Anxiety Scale）> 50 or SDS（Self-rating Depression Scale）> 53, or with other psychiatric disorders;
- With history of cardiovascular, respiratory, digestive, urinary, and hematologic disease, which can't controlled through common treatment. Either with cancer, infection, electrolyte imbalance, acid-base disturbance and calcium metabolic disorder.
- Allergic to any medicine or ingredients used in this study.
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- Participating other clinical trials or participated within 1 month.
- Topical treatments (i.e. corticosteroids, Retinoic acid) within 2 weeks; systemic therapy or phototherapy (UVB and PUVA) within 4 weeks; biological therapy within 12 weeks.
- Patients need systemic treatment prescribed by doctors.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
Guangzhou, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Chinese herbal PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of Chinese Medicine.
Read the detailed description
Psoriasis is an immune-abnormal, chronic, proliferative skin disease characterized by scaly, erythematous patches and papules. An epidemiological survey found Chinese prevalence showed an upward trend in recent years. The disease has great influence on patients' appearance,health and quality of life. Some Chinese Herbal Medicine (CHM) therapies have shown long lasting therapeutic effect on controlling psoriasis vulgaris and with minimal side effects.CHM can alleviate the symptoms effectively,and reduce the recurrence rate of diseases. PSORI-CM01（YXBCM01）granule is one kind of CHM which is observed effective and safe to treat stable stable plaque psoriasis with blood stasis syndrome in clinical practice.
- Conditions
- Plaque Psoriasis
- Being tested
- PSORI-CM01（YXBCM01） granule, placebo
- Keywords
- Stable Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSORI-CM01（YXBCM01） granuleDrug
Also called Chinese Hebal Medicine
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| PSORI-CM01（YXBCM01）granule | Experimental | PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks. Receives: Drug: PSORI-CM01（YXBCM01） granule |
| PSORI-CM01（YXBCM01）granule low dose group | Experimental | PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks. Receives: Drug: PSORI-CM01（YXBCM01） granule; Drug: placebo |
| placebo | Placebo comparator | Placebo granule 1.1g os once a day for 12weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI-50
The number of patients who achieve at least 50% improvement in PASI score from baseline.
Measured: 12 weeks (plus or minus 3 days) after treatment
Secondary outcomes (9)
PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline.
Measured: 12 weeks (plus or minus 3 days) after treatment
PASI-75
The number of patients who achieve at least 75% improvement in PASI score from baseline.
Measured: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Measured: 12 weeks (plus or minus 3 days) after treatment
BSA（Body Surface Area）
the Body Surface Area
Measured: 12 weeks (plus or minus 3 days) after treatment
DLQI（Dermatology Life Quality Index）
the Dermatology Quality Life Index
Measured: 12 weeks (plus or minus 3 days) after treatment
Relapse rate in treatment period / follow-up period
Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.
Measured: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Time interval for patients the first time to achieve PASI-50 from baseline
Measured: During the treatment period of 12 weeks
Relapse time interval
Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs.
Measured: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Rebound rate
Rebound can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score increase up to 25% from the baseline PASI score.
Measured: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionOct 2015
Why it stopped: Paitents were unwilling to be randomly assigned to a placebo group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Chuanjian Lu, Doctor, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153840
- Sponsor's protocol ID
- 201105
- Status last verified
- Jul 2017
- First submitted
- 24 May 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02153840
- Acronym / sponsor ID
- 201105
- Conditions
- Plaque Psoriasis
- Keywords
- Stable Plaque Psoriasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Paitents were unwilling to be randomly assigned to a placebo group.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to evaluate the efficacy and safety of Chinese herbal PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of Chinese Medicine.
Detailed description
Psoriasis is an immune-abnormal, chronic, proliferative skin disease characterized by scaly, erythematous patches and papules. An epidemiological survey found Chinese prevalence showed an upward trend in recent years. The disease has great influence on patients' appearance,health and quality of life. Some Chinese Herbal Medicine (CHM) therapies have shown long lasting therapeutic effect on controlling psoriasis vulgaris and with minimal side effects.CHM can alleviate the symptoms effectively,and reduce the recurrence rate of diseases. PSORI-CM01（YXBCM01）granule is one kind of CHM which is observed effective and safe to treat stable stable plaque psoriasis with blood stasis syndrome in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSORI-CM01（YXBCM01）granule | Experimental | Drug: PSORI-CM01（YXBCM01） granulePSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks. |
| PSORI-CM01（YXBCM01）granule low dose group | Experimental | Drug: PSORI-CM01（YXBCM01） granule, Drug: placeboPSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks. |
| placebo | Placebo comparator | Drug: placeboPlacebo granule 1.1g os once a day for 12weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable plaque psoriasis, duration > 1 year.
- Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient.
- Mild psoriasis:3<PASI≤10, and BSA≤10%.
- Informed consent.
Key exclusion criteria (9 listed)
- Guttate psoriasis, inverse psoriasis or exclusively involves the face;
- Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis.
- Pregnant, lactating, or which one plan to become pregnant in a year;
- SAS（Self-rating Anxiety Scale）> 50 or SDS（Self-rating Depression Scale）> 53, or with other psychiatric disorders;
- With history of cardiovascular, respiratory, digestive, urinary, and hematologic disease, which can't controlled through common treatment. Either with cancer, infection, electrolyte imbalance, acid-base disturbance and calcium metabolic disorder.
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 |
|---|---|---|
| PSORI-CM01（YXBCM01） granuleAlso: Chinese Hebal Medicine | Drug | PSORI-CM01（YXBCM01）granule, PSORI-CM01（YXBCM01）granule low dose group |
| placebo | Drug | PSORI-CM01（YXBCM01）granule low dose group, placebo |
Primary outcome
PASI-50
Time frame: 12 weeks (plus or minus 3 days) after treatment
The number of patients who achieve at least 50% improvement in PASI score from baseline.
9 secondary outcomes
PASI(Psoriasis Area and Severity Index)
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-75
Time frame: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Time frame: 12 weeks (plus or minus 3 days) after treatment
BSA（Body Surface Area）
Time frame: 12 weeks (plus or minus 3 days) after treatment
DLQI（Dermatology Life Quality Index）
Time frame: 12 weeks (plus or minus 3 days) after treatment
Relapse rate in treatment period / follow-up period
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Time interval for patients the first time to achieve PASI-50 from baseline
Time frame: During the treatment period of 12 weeks
Relapse time interval
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Rebound rate
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Results and safety
The study was stopped early (reason given: Paitents were unwilling to be randomly assigned to a placebo group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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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.
Chuanjian Lu, Doctor principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSORI-CM01（YXBCM01） granule in people with Plaque Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 3 sites 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study was stopped early (reason given: Paitents were unwilling to be randomly assigned to a placebo group.). Results are not available in the source record.
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?
PASI-50 (time frame: 12 weeks (plus or minus 3 days) after treatment). 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 1 Aug 2017.