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| Name | Class |
|---|---|
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
| The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | OTHER |
| Shijiazhuang Hospital of Traditional Chinese Medicine | UNKNOWN |
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We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.
Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. In addition, blood-stasis accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for so long, which similar to many metabolic related diseases. Therefore, the method of promoting blood circulation and removing blood stasis has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Taodan granule, a representative prescription for the treatment of psoriasis with blood stasis syndrome, in the treatment of psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Chinese medicine | Experimental | Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks. |
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| Oral Chinese medicine placebo | Placebo Comparator | Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taodan Granules | Drug | Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index (PASI) | Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis. | Up to 56 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Body surface area (BSA) | The percentage of body surface area (BSA) involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%) | Up to 56 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li | Contact | 0086-021-55981301 | 18930568129@163.com | |
| Jie Chen | Contact | 0086-021-65161782-3137 | dercj366@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Zhou | Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shijiazhuang Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | China | |||
| First Affiliated Hospital of Heilongjiang Chinese Medicine University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31700924 | Derived | Ru Y, Yan XN, Yang SQ, Gong LP, Li LE, Chen J, Zhao YD, An YP, Huang G, Zhang JF, Yin QF, Wang RP, Li X, Li B. Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial. Ann Transl Med. 2019 Sep;7(18):488. doi: 10.21037/atm.2019.09.05. |
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| Heilongjiang University of Chinese Medicine | OTHER |
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| Taodan Granules Placebo | Drug | Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute. |
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| Physician Global Assessment (PGA) | Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)]. | Up to 56 days after treatment |
| Dermatology Life quality index(DLQI) | The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life. | Up to 56 days after treatment |
| Patient-reported quality of life (PRQoL) | Patient-reported quality of life (PRQoL) is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life. | Up to 56 days after treatment |
| Visual Analogue Score (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis). | Up to 56 days after treatment |
| TCM symptom score | The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 56 days after treatment |
| Harbin |
| Heilongjiang |
| China |
| Affiliated hospital of jiangxi university of traditional Chinese medicine | Nanchang | Jiangxi | China |
| Shanghai Yueyang Integrated Medicine Hospital | Shanghai | Shanghai Municipality | China |
| Shanxi Provincial Hospital of Traditional Chinese Medicine | Xi’an | Shanxi | China |