An Open Label, Prospective, Non-Comparative, Single Arm Pilot Clinical Study to Evaluate the Safety and Effectiveness of â??Sorajit Capsulesâ?? of SG Phyto Pharma Pvt. Ltd. in Chronic Plaque Psoriasis in Adults.

SG Phyto Pharma Pvt Ltd0 个研究点目标入组 26 人开始时间: 待定最近更新: 2023年2月6日

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 26

研究概览入排标准研究者记录与标识符相似试验

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. Adults aged between 21 and 65 years -both ages and all genders inclusive-, diagnosed with Psoriasis vulgaris
•i. Psoriasis vulgaris: Plaque psoriasis
•ii. Type I and Type II
•iii. Moderate Severity: BSA 3%-10%
•2. Subjects who are willing to abstain from use of any and medication or supplementation intended for the treatment or management of psoriasis not limited to oral, IV, IM, ID, topical therapy regimens.
•3. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
•4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

排除标准

•1. Subjects with known hypersensitivity to herbal investigational product or its constituents.
•2. Subjects with any other dermatological conditions not limited to scarring of the body surface intended for clinical examination
•3. Subjects with immunucompromised state complications.
•4. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he or she participates in the study.
•5. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
•6. Subjects with history of substance abuse or in sobriety for less than 3 years at the time of screening.
•7. Subjects with history of cancer or in remission for less than 3 years at the time of screening.
•8. Subjects who have had a major surgery less than 6 months at the time of screening.
•9. Women who are pregnant, nursing or have had active pregnancy or miscarriage less than 1 year prior to the time of screening.
•10. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor -e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
•11. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
•12. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•13. Subjects, who in the opinion of the Investigator, are not eligible for enrolment in the study.

研究者

发起方

SG Phyto Pharma Pvt Ltd

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