Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
NCT ID: NCT03942185
Last Updated: 2019-05-08
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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UNKNOWN
PHASE2
2000 participants
INTERVENTIONAL
2019-06-01
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Healthy control group
No Intervention.
No interventions assigned to this group
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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.
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
2. Other reasons that the investigator considered inappropriate to participate in the study.
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Zhejiang Provincial Hospital of TCM
OTHER
Shanghai Dermatology Hospital
OTHER
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
Changhai Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Beijing Hospital of Traditional Chinese Medicine
OTHER
Wuhan No.1 Hospital
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Chinese Medicine Hospital Affiliated to Southwest Medical University
UNKNOWN
First Affiliated Hospital of Heilongjiang Chinese Medicine University
OTHER
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
OTHER
The Second Affiliated Hospital of Jiangxi University of TCM
UNKNOWN
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
UNKNOWN
The First Affiliated Hospital of Guiyang College of TCM
UNKNOWN
The Second People's Hospital Affiliated to Fujian University of TCM
UNKNOWN
Gansu University of Chinese Medicine
OTHER
Shanxi Provincial Hospital of Traditional Chinese Medicine
UNKNOWN
Shijiazhuang Hospital of Traditional Chinese Medicine
UNKNOWN
Shanghai Yueyang Integrated Medicine Hospital
OTHER
Responsible Party
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Principal Investigators
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Jia Zhou
Role: STUDY_CHAIR
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Locations
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The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
The Second People's Hospital Affiliated to Fujian University of TCM
Fuzhou, Fujian, China
Affiliated Hospital of Gansu University of traditional Chinese Medicine
Lanzhou, Gansu, China
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
Nanning, Guangxi, China
The First Affiliated Hospital of Guiyang College of TCM
Guiyang, Guizhou, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Affiliated hospital of jiangxi university of traditional Chinese medicine
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Jiangxi University of TCM
Nanchang, Jiangxi, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi’an, Shanxi, China
Chinese Medicine Hospital Affiliated to Southwest Medical University
Luzhou, Sichuan, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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References
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Sun X, Zhao H, Wang R, Li H, Wu Y, Ze K, Su Y, Li B, Li X. Psoriasis complicated with metabolic disorder is associated with traditional Chinese medicine syndrome types: a hospital-based retrospective case-control study. Curr Med Res Opin. 2023 Jan;39(1):19-25. doi: 10.1080/03007995.2022.2129803. Epub 2022 Oct 11.
Luo Y, Ru Y, Sun X, Zhou Y, Yang Y, Ma T, Xu R, Chen J, Zhou M, Ze K, Ju L, Wang Y, Yin Q, Wang R, Li B, Li X. Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol. Ann Transl Med. 2019 Nov;7(22):694. doi: 10.21037/atm.2019.10.46.
Other Identifiers
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2018YFC1705301
Identifier Type: -
Identifier Source: org_study_id
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