Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis
NCT ID: NCT02153840
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
35 participants
INTERVENTIONAL
2013-12-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PSORI-CM01（YXBCM01）granule
PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.
PSORI-CM01（YXBCM01） granule
PSORI-CM01（YXBCM01）granule low dose group
PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
PSORI-CM01（YXBCM01） granule
placebo
placebo
Placebo granule 1.1g os once a day for 12weeks.
placebo
Interventions
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PSORI-CM01（YXBCM01） granule
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient.
3. Mild psoriasis:3\<PASI≤10, and BSA≤10%.
4. Informed consent.
Exclusion Criteria
2. Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis.
3. Pregnant, lactating, or which one plan to become pregnant in a year;
4. SAS（Self-rating Anxiety Scale）\> 50 or SDS（Self-rating Depression Scale）\> 53, or with other psychiatric disorders;
5. 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.
6. Allergic to any medicine or ingredients used in this study.
7. Participating other clinical trials or participated within 1 month.
8. 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.
9. Patients need systemic treatment prescribed by doctors.
18 Years
65 Years
ALL
No
Sponsors
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Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Chuanjian Lu
Doctor
Principal Investigators
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Chuanjian Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Locations
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Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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201105
Identifier Type: -
Identifier Source: org_study_id
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