Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial of Efficacy and Safety of Jiuweihuaban Pill in the Treatment of Moderate to Severe Plaque Psoriasis(Syndrome of Blood-heat ).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06058546
• Other study ID #: TSL-TCM-JWHBW-?
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343626
• Email: liurui2[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged 18-65, male or female.

2. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria

3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.

4. At screening period: 3 =PASI= 20, 3%=BSA= 10% and sPGA=2.

5. Willing to participate voluntarily and sign a written informed consent.

Exclusion Criteria:

1. Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles.

2. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.

3. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study.

4. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others

5. Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.

6. Systemic anti-infective treatment received within the 4 weeks prior to randomization; presence of recurrent, chronic, or active infection at baseline as determined by the investigator and judged to increase the subject's risk.

7. With a serious, progressive, or uncontrolled disease, including but not limited to a disease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary, and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, or infectious system, a malignancy.

8. Patients with serum creatinine above the upper limit of normal at screening, with elevated Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels = 1.5 times the upper limit of normal.

9. Participation in other clinical trials and received investigational drugs within 1 month prior to screening.

10. Patients with hypersensitivity to the investigational drug components.

11. Patients had a history of smoking, alcohol, drug abuse.

12. Patients (including partners) have plans to become pregnant from 2 weeks before the first dose to 1 month after the last dose and Subjects do not take effective contraceptive measures during this period or during pregnancy or breastfeeding

13. Any other situation that the investigator did not consider suitable for participation in the study, such as other skin problems that hinder the assessment of Psoriasis, potential compliance problems, inability to complete all examinations and evaluations in accordance with the protocol requirements, may pose an uncontrollable risk for participation in the study.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Jiuweihuaban Pill placebo
Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.
• low dose Jiuweihuaban Pill
Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.
• high dose Jiuweihuaban Pill
High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Locations

Country	Name	City	State
China	Beijing traditional Chinese medicine hospital affiliated to Capital Medical University	Beijing
China	Affiliated Hospital of Changchun University of Traditional Chinese Medicine	Changchun
China	The First Affiliated Hospital of Hunan University of Chinese Medicine	Changsha
China	Chengdu Second People's Hospital	Chengdu
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan
China	Yunnan Provincial Hospital of Traditional Chinese Medicine	Kunming
China	Nanyang First People's Hospital	Nanyang
China	The First Affiliated Hospital of China Medical University	Shenyang
China	Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine	Tianjin
China	First affiliated hospital of Wenzhou medical university	Wenzhou
China	The Second Affiliated Hospital of Xiamen Medical College	Xiamen
China	Xingtai people's hospital	Xingtai

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI 75	Proportion of subjects achieving an improvement of =75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.	Baseline to days 84.
Secondary	PASI75	Proportion of subjects achieving an improvement of =75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28?56.	Baseline to days 28?56.
Secondary	PASI50?90	Proportion of subjects achieving an improvement of =50% and =90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28?56?84.	Baseline to days 28?56?84.
Secondary	Change value and percentage change in PASI score	Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.	Baseline to days 84.
Secondary	Proportion of subjects achieving sPGA=0 or 1	Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.	Baseline to days 28?56?84.
Secondary	Proportion of subjects achieving an improvement of =2 points in sPGA	Proportion of subjects achieving an improvement of =2 points in static Physician Global Assessment from baseline at days 28?56?84.	Baseline to days 28?56?84.
Secondary	Change value and percentage change in BSA affected by psoriasis	Change value and percentage change in Body Surface Area (BSA) affected by psoriasis from baseline at days 28?56?84.	Baseline to days 28?56?84.
Secondary	Change value and percentage change in NRS for skin itching	Change value and percentage change in Numeric Rating Scale (NRS) for skin itching from baseline at days 28?56?84. The NRS scores can range from 0,corresponding to no itching symptom,up to a maximum of 10,corresponing to the most severe itching .	Baseline to days 28?56?84.
Secondary	Change value and percentage change in DLQI score	Change value and percentage change in Dermatology Life Quality Index (DLQI) score from baseline at days 28?56?84. The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.	Baseline to days 28?56?84.
Secondary	Proportion of subjects achieving DLQI=0-1	Proportion of subjects achieving a DLQI score of 0-1 (DLQI=0-1) at days 28?56?84.The DLQI scores can range from 0 to 30.The higher the score, the worse the quality of life.	Baseline to days 28?56?84.
Secondary	Change value and percentage change in Traditional Chinese Medicine Syndrome score	Change value and percentage change in Traditional Chinese Medicine Syndrome score from baseline at days 28?56?84.The Traditional Chinese Medicine Syndrome scores can range from 0 to 27.The higher the score, the more severe psoriasis.	Baseline to days 28?56?84.
Secondary	Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome	Disappearance rate of individual symptoms in Traditional Chinese Medicine Syndrome at days 28?56?84.	Baseline to days 28?56?84.