Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06058546
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tasly Pharmaceutical Group Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions

Arms

Placebo Comparator: Placebo group

Jiuweihuaban Pill placebo, 1 bag each time, p.o. , tid

Experimental: Low dose group

Jiuweihuaban Pill , 1 bag each time, p.o. , tid

Experimental: High dose group

Jiuweihuaban Pill , 1 bag each time, p.o. , tid

Interventions

Drug: - Jiuweihuaban Pill placebo

Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.

Drug: - 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.

Drug: - high dose Jiuweihuaban Pill

High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Address

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Beijing, ,

Site Contact

Dongmei Zhou

52176857@163.com

13811201580

Changchun, China

Status

Address

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, ,

Site Contact

Ying Sun

30636379@qq.com

13624300207

Changsha, China

Status

Address

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, ,

Site Contact

Jianyuan Xi

syfzb9068@sina.cn

15974172722

Chengdu Second People's Hospital, Chengdu, China

Status

Address

Chengdu Second People's Hospital

Chengdu, ,

Site Contact

Yanyan Feng

Yolanda20220918@163.com

13999163793

Jinan, China

Status

Address

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, ,

Site Contact

Chiu Isabella

zhaoyingszy@163.com

13210516416

Kunming, China

Status

Address

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, ,

Site Contact

Xiaoyong Ouyang

oyxy68@126.com

13708446568

Nanyang First People's Hospital, Nanyang, China

Status

Address

Nanyang First People's Hospital

Nanyang, ,

Site Contact

Rixin Chen

pfkgcpby@163.com

13849795170

Shenyang, China

Status

Address

The First Affiliated Hospital of China Medical University

Shenyang, ,

Site Contact

Long Geng

genglong99@126.com

13709853622

Tianjin, China

Status

Address

Affiliated Hospital of Tianjin Institute of Traditional Chinese Medicine

Tianjin, ,

Site Contact

Litao Zhang

zhanglitao@medmail.com.cn

18602228122

Wenzhou, China

Status

Address

First affiliated hospital of Wenzhou medical university

Wenzhou, ,

Site Contact

Zhiming Li

zhi-mingli@163.com

15988718867

Xiamen, China

Status

Address

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, ,

Site Contact

mingkai Ji

Mingkai_ji@163.com

13075959049

Xingtai people's hospital, Xingtai, China

Status

Address

Xingtai people's hospital

Xingtai, ,

Site Contact

Fang Cheng

18931912286@163.com

18931912286

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