A Phase 2 interventional study of Jueyin granules and Jueyin Granules Placebo in Psoriasis Vulgaris, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Status unknown at 4 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Phase 2, Interventional, and Treatment
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.
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. Chinese medicine believes that the blood heat is the root of the onset of psoriasis, so the treatment of psoriasis should focus on the method of clearing heat and cooling blood. Therefore, the method of promoting clearing heat and cooling blood. 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 Jueyin granule, a representative prescription for the treatment of psoriasis with blood heat syndrome, in the treatment of psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's planned enrollment of 196 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Participants in experimental group will receive Jueyin granule two times daily after meals three times per week for 8 weeks.
Drug: Jueyin granules
Participants in placebo group will receive Jueyin granule placebo two times daily after meals three times per week for 8 weeks.
Drug: Jueyin 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.
Also known as: Chinese Herbal Medicine
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.
Also known as: Chinese Herbal Medicine
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.
Time frame: Up to 56 days after treatment.
Body surface area (BSA)
The percentage of 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 (%)
Time frame: Up to 56 days after treatment.
Physician Global Assessment (PGA)
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 \[PGA scale: Clear (0) - Very Severe (5)\].
Time frame: Up to 56 days after treatment.
Dermatology Life quality index(DLQI)
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.
Time frame: Up to 56 days after treatment.
Patient-reported quality of life (PRQoL)
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.
Time frame: Up to 56 days after treatment.
Visual Analogue Score (VAS)
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).
Time frame: Up to 56 days after treatment.
TCM symptom score
The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Time frame: Up to 56 days after treatment.
Plan to share: Undecided
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Shanghai Yueyang Integrated Medicine Hospital