CTRI/2023/05/053308尚未招募3 期
An Open Label Prospective Clinical Study to evaluate the effects of N-163 strain of Aureobasidium Pullulans Produced β 1,3-16 Glucans in modulating the immunity in patients with Psoriasis
ichi-In Bio Sciences Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males and females at least 18 years of age.
- •2. Except for plaque psoriasis with or without arthritis, subject is in generally good health.
- •3. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis ( > 5% body surface area (BSA) involvement).
- •4. Signed, written informed consent
- •5. Willing and able to comply with study visits according to protocol for the full study period
排除标准
- •1. Patients with forms of psoriasis other than chronic plaque-type psoriasis or with drug-induced psoriasis
- •2. Use of an investigational drug within 90 days prior to Day 1.
- •3. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
- •4. Patient with any active or chronic infection
- •5. Pregnancy or risk of pregnancy.
- •6. Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
- •7. Patients unable to give written informed consent
研究者
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