Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes; 2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included); 3. Age between 18 and 65 years old; 4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis; 2. Other active skin diseases may affect the condition assessment; 3. Received research drugs, biological agents and immunosuppressive agents within 1 month; 4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.; 5. During severe, uncontrollable local or systemic acute or chronic infections; 6. Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial; 7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity; 8. Such surgery will be required during major surgery or study during 8 weeks; 9. Pregnant or lactating women; 10. A person with a history of alcohol abuse, drug abuse or drug abuse; 11. Have a history of serious mental illness or family history; 12. Other reasons researchers believe that it is inappropriate to participate in this research.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03942198
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Yueyang Integrated Medicine Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jia Zhou
Principal Investigator Affiliation Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

Experimental: Oral Chinese medicine

Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Placebo Comparator: Oral Chinese medicine placebo

Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Interventions

Drug: - Taodan Granules

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.

Drug: - Taodan Granules Placebo

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shijiazhuang, He Bei, China

Status

Address

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, He Bei,

Harbin, Heilongjiang, China

Status

Address

First Affiliated Hospital of Heilongjiang Chinese Medicine University

Harbin, Heilongjiang,

Nanchang, Jiangxi, China

Status

Address

Affiliated hospital of jiangxi university of traditional Chinese medicine

Nanchang, Jiangxi,

Shanghai, Shanghai, China

Status

Address

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai,

Xi'an, Shanxi, China

Status

Address

Shanxi Provincial Hospital of Traditional Chinese Medicine

Xi'an, Shanxi,

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