Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study
1 other identifier
interventional
2,000
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 8, 2019
May 1, 2019
2.6 years
May 7, 2019
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psoriasis Area and Severity Index
Psoriasis Area and Severity Index 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
Secondary Outcomes (6)
Body surface area (BSA)
Up to 56 days after treatment
Physician Global Assessment (PGA)
Up to 56 days after treatment
Dermatology Life quality index(DLQI)
Up to 56 days after treatment
Patient-reported quality of life (PRQoL)
Up to 56 days after treatment
Visual Analogue Score (VAS)
Up to 56 days after treatment
- +1 more secondary outcomes
Study Arms (4)
Psoriasis with Blood heat syndrome group
EXPERIMENTALParticipants 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.
Psoriasis with Blood stasis syndrome group
EXPERIMENTALParticipants 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.
Psoriasis with Non-Blood heat or Blood stasis syndrome group
EXPERIMENTALParticipants 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.
Healthy control group
NO INTERVENTIONNo Intervention.
Interventions
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, 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, warm water decoction, 1 dose/day, divided into 2 times, 180 \~ 200ml each time for 8 weeks.
Eligibility Criteria
You may qualify if:
- In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
- to 65 years old, male or female patient;
- The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
- Informed consent must be obtained.
You may not qualify if:
- Patients with a history of serious mental illness or family history;
- Other reasons that the investigator considered inappropriate to participate in the study.
- Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
- to 65 years old, male or female patient;
- The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
- Informed consent must be obtained.
- Other active skin diseases which may affect the condition assessment are present;
- Those with severe, uncontrollable local or systemic acute or chronic infections;
- Patients with a history of serious mental illness or family history;
- Other reasons that the investigator considered inappropriate to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Yueyang Integrated Medicine Hospitallead
- Zhejiang Provincial Hospital of TCMcollaborator
- Shanghai Dermatology Hospitalcollaborator
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- Changhai Hospitalcollaborator
- Shanghai 10th People's Hospitalcollaborator
- Beijing Hospital of Traditional Chinese Medicinecollaborator
- Wuhan No.1 Hospitalcollaborator
- Jiangsu Province Hospital of Traditional Chinese Medicinecollaborator
- Chinese Medicine Hospital Affiliated to Southwest Medical Universitycollaborator
- First Affiliated Hospital of Heilongjiang Chinese Medicine Universitycollaborator
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicinecollaborator
- The Second Affiliated Hospital of Jiangxi University of TCMcollaborator
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicinecollaborator
- The Guangxi Zhuang Autonomous Region Institute of Dermatology and controlcollaborator
- The First Affiliated Hospital of Guiyang College of TCMcollaborator
- The Second People's Hospital Affiliated to Fujian University of TCMcollaborator
- Gansu University of Chinese Medicinecollaborator
- Shanxi Provincial Hospital of Traditional Chinese Medicinecollaborator
- Shijiazhuang Hospital of Traditional Chinese Medicinecollaborator
Study Sites (20)
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
Related Publications (2)
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.
PMID: 36189747DERIVEDLuo 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.
PMID: 31930095DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Zhou
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 8, 2019
Study Start
June 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 8, 2019
Record last verified: 2019-05