Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

Psoriasis Vulgaris Clinical Trial

Official title:

Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03942198
• Other study ID #: 2018YFC1705303-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2019
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Bin Li
• Phone: 0086-021-55981301
• Email: 18930568129[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Taodan Granules
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.
• Taodan 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.

Locations

Country	Name	City	State
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	Shijiazhuang Hospital of Traditional Chinese Medicine	Shijiazhuang	He Bei
China	Shanxi Provincial Hospital of Traditional Chinese Medicine	Xi'an	Shanxi

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital	Affiliated hospital of jiangxi university of traditional Chinese medicine, Heilongjiang University of Chinese Medicine, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis area and severity index (PASI)	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.	Up to 56 days after treatment
Secondary	Body surface area (BSA)	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 (%)	Up to 56 days after treatment
Secondary	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)].	Up to 56 days after treatment
Secondary	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.	Up to 56 days after treatment
Secondary	Patient-reported quality of life (PRQoL)	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.	Up to 56 days after treatment
Secondary	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).	Up to 56 days after treatment
Secondary	TCM symptom score	The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.	Up to 56 days after treatment