Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine

Plaque Psoriasis Clinical Trial

Official title:

Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03941431
• Other study ID #: 2018YFC1705304
• 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

The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.

Description:

Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.

The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, controlled trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 378
• 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. Plaque psoriasis, the course of disease is not limited.

2. Skin lesions involving = 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).

3. 18 to 65 years old, male or female patient.

4. Informed consent must be obtained.

Exclusion Criteria:

1. other active skin diseases which may affect the condition assessment are present.

2. Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.

3. Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.

4. Those with severe, uncontrollable local or systemic acute or chronic infections.

5. patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by >1.5 times the upper limit of normal; serum creatinine increased by >1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.

6. Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.

7. Patients underwent major surgery within 8 weeks or will require such surgery during the study period.

8. Patients who are pregnant or in lactation.

9. Those have a history of alcohol abuse, drug abuse or drug abuse.

10. Patients with a history of serious mental illness or family history.

11. Patients with a family history of cancer.

12. Other reasons that the investigator considered inappropriate to participate in the study.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Jueyin granules
Jueyin granules p.o. once a day for 8 weeks.

Device:
• moving cupping therapy
Moving cupping therapy three times per week for 8 weeks.
• NB-UVB therapy
NB-UVB phototherapy three times per week for 8 weeks.

Drug:
• Jueyin placebo granules
Jueyin placebo granules p.o. once a day for 8 weeks.

Device:
• moving cupping placebo therapy
Moving cupping placebo therapy three times per week for 8 weeks.
• NB-UVB placebo phototherapy
NB-UVB placebo phototherapy three times per week for 8 weeks.

Locations

Country	Name	City	State
China	The Second People's Hospital Affiliated to Fujian University of TCM	Fuzhou	Fujian
China	Chinese Medicine Hospital Affiliated to Southwest Medical University	Luzhou	Sichuan
China	Jiangsu Province Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Shanghai Dermatology Hospital	Shanghai
China	Shanghai Yueyang Integrated Medicine Hospital	Shanghai
China	Wuhan No.1 Hospital	Wuhan	Hubei

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital	Chinese Medicine Hospital Affiliated to Southwest Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Shanghai Dermatology Hospital, The Second People's Hospital Affiliated to Fujian University of TCM, Wuhan No.1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 (%)	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)	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.