- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942198
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome
May 7, 2019 updated by: Shanghai Yueyang Integrated Medicine Hospital
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
216
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Chen
- Phone Number: 0086-021-65161782-3137
- Email: dercj366@163.com
Study Locations
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He Bei
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Shijiazhuang, He Bei, China
- Shijiazhuang Hospital of Traditional Chinese Medicine
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Heilongjiang
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Harbin, Heilongjiang, China
- First Affiliated Hospital of Heilongjiang Chinese Medicine University
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Jiangxi
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Nanchang, Jiangxi, China
- Affiliated hospital of jiangxi university of traditional Chinese medicine
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Yueyang Integrated Medicine Hospital
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Shanxi
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Xi'an, Shanxi, China
- Shanxi Provincial Hospital of Traditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
- 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);
- Age between 18 and 65 years old;
- Those who voluntarily participate in the study and sign informed consent.
Exclusion Criteria:
- Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- Other active skin diseases may affect the condition assessment;
- Received research drugs, biological agents and immunosuppressive agents within 1 month;
- 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- During severe, uncontrollable local or systemic acute or chronic infections;
- 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;
- A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
- Such surgery will be required during major surgery or study during 8 weeks;
- Pregnant or lactating women;
- A person with a history of alcohol abuse, drug abuse or drug abuse;
- Have a history of serious mental illness or family history;
- Other reasons researchers believe that it is inappropriate to participate in this research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oral Chinese medicine
Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks.
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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.
Other Names:
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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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psoriasis area and severity index (PASI)
Time Frame: Up to 56 days after treatment
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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.
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Up to 56 days after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Global Assessment (PGA)
Time Frame: Up to 56 days after treatment
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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)].
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Up to 56 days after treatment
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Dermatology Life quality index(DLQI)
Time Frame: Up to 56 days after treatment
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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.
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Up to 56 days after treatment
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Visual Analogue Score (VAS)
Time Frame: Up to 56 days after treatment
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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).
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Up to 56 days after treatment
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Body surface area (BSA)
Time Frame: Up to 56 days after treatment
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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 (%)
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Up to 56 days after treatment
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Patient-reported quality of life (PRQoL)
Time Frame: Up to 56 days after treatment
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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.
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Up to 56 days after treatment
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TCM symptom score
Time Frame: Up to 56 days after treatment
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The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
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Up to 56 days after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2019
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
May 7, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (ACTUAL)
May 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 8, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018YFC1705303-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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