Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

Study Purpose

The purpose of this study is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
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 of psoriatic: 1. In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 2. 18 to 65 years old, male or female patient; 3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; 4. Informed consent must be obtained. Exclusion Criteria of psoriatic: 1. Patients with a history of serious mental illness or family history; 2. Other reasons that the investigator considered inappropriate to participate in the study. Inclusion Criteria of health volunteers: 1. Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 2. 18 to 65 years old, male or female patient; 3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; 4. Informed consent must be obtained. Exclusion Criteria of health volunteers: 1. Other active skin diseases which may affect the condition assessment are present; 2. Those with severe, uncontrollable local or systemic acute or chronic infections; 3. Patients with a history of serious mental illness or family history; 4. Other reasons that the investigator considered inappropriate to participate in the study.

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.	NCT03942185
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

Additional Details

Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost. Chinese Medicine (CM) has unique advantages in treatment of psoriasis. On the basis of CM principle--"Blood Differentiation and Treatment" in psoriasis and the combination of clinical experience, Chinese famous professor Wanzhang Qin proposed the "New Blood Syndrome Theory" in psoriasis--the psoriasis based in blood, with blood heat first, and blood stasis throughout the whole process of psoriasis. This study will form a systematic report on the diagnosis and treatment of psoriasis with the New Blood Syndrome Theory; theoretically verified by prospective cohort studies, a theoretical system of the New Blood Syndrome Theory for psoriasis will be constructed. Objectives of this study are to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Arms & Interventions

Arms

Experimental: Psoriasis with Blood heat syndrome group

Participants in Psoriasis with Blood heat syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Clearing heat and Cooling blood, such as Cool blood detoxification Decoction I，Cool blood and activating blood prescription compound, Cool blood detoxification Decoction II, Cool blood activating blood Decoction, Tufu drink, Xiaoyin Decoction and etc., two times per day for 8 weeks.

Experimental: Psoriasis with Blood stasis syndrome group

Participants in Psoriasis with Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Promoting blood circulation and Removing blood stasis, such as Huoxue Sanyu Xiaoyin Decoction, Cool blood detoxification Decoction III and etc., two times per day for 8 weeks.

Experimental: Psoriasis with Non-Blood heat or Blood stasis syndrome group

Participants in Psoriasis with Non-Blood heat or Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of syndrome differentiation therapy two times per day for 8 weeks.

No Intervention: Healthy control group

No Intervention.

Interventions

Drug: - Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy

Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Drug: - Oral Chinese Herbal Medicine according with syndrome differentiation therapy

Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Drug: - Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy

Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Contact a Trial Team

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International Sites

Hefei, Anhui, China

Status

Address

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Hefei, Anhui,

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