Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

Phase 2

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Taodan Granules; Drug: Taodan Granules Placebo

• Registration Number: NCT03942198
• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Last Update Submitted: 2019-05-07
• Study First Posted: 2019-05-08
• Last Update Posted: 2019-05-08
• Study Start: 2019-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
2. 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);
3. Age between 18 and 65 years old;
4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
2. Other active skin diseases may affect the condition assessment;
3. Received research drugs, biological agents and immunosuppressive agents within 1 month;
4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
5. During severe, uncontrollable local or systemic acute or chronic infections;
6. 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;
7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
8. Such surgery will be required during major surgery or study during 8 weeks;
9. Pregnant or lactating women;
10. A person with a history of alcohol abuse, drug abuse or drug abuse;
11. Have a history of serious mental illness or family history;
12. Other reasons researchers believe that it is inappropriate to participate in this research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Chinese medicine	Taodan Granules	Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks.
Oral Chinese medicine placebo	Taodan Granules Placebo	Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Psoriasis area and severity index (PASI)	Up to 56 days after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Body surface area (BSA)	Up to 56 days after treatment	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 (%)
Physician Global Assessment (PGA)	Up to 56 days after treatment	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 \[PGA scale: Clear (0) - Very Severe (5)\].
TCM symptom score	Up to 56 days after treatment	The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Patient-reported quality of life (PRQoL)	Up to 56 days after treatment	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.
Visual Analogue Score (VAS)	Up to 56 days after treatment	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).
Dermatology Life quality index(DLQI)	Up to 56 days after treatment	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.

Trial Locations

Locations (5)

Shijiazhuang Hospital of Traditional Chinese Medicine; 🇨🇳 Shijiazhuang, He Bei, China

First Affiliated Hospital of Heilongjiang Chinese Medicine University; 🇨🇳 Harbin, Heilongjiang, China

Affiliated hospital of jiangxi university of traditional Chinese medicine; 🇨🇳 Nanchang, Jiangxi, China

Shanghai Yueyang Integrated Medicine Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanxi Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Xi'an, Shanxi, China