An open label, prospective, phase II, clinical study to evaluate efficacy and safety of Barphani Ointment in patients suffering from Chronic Plaque Psoriasis.

Ayurved Sanshodhan Vibhag0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Male or Female Subjects in the age group of 18 to 60 years, both
•2. Subjects with confirmed diagnosis of plaque psoriasis since at least 6
•3. Subjects must have active plaque psoriasis for atleast 10 % of body surface area.
•4. Subjects with plaque psoriasis having PASI score >10
•5.Subjects of female gender or non-pregnant, non-lactating females. A
•urine pregnancy test is required for all female subjects of childbearing
•potential unless subject has had a hysterectomy, tubal ligation, or is > 2
•years postmenopausal.
•6.Subjects willing to follow the procedures as per the study protocol and
•voluntarily sign an informed consent form.

•1.Subjects who have received systemic treatment for Psoriasis such as
•Methotrexate or Cyclosporine therapy or any conventional systemic treatment
•for more than 4 weeks one month prior to screening in the study.
•2.Any laser dermatological procedure, 4 weeks prior to screening in this study
•3.Known cases of Severe/Chronic hepatic or renal disease.
•4.Known case of any active malignancy.
•5. Subjects giving history of significant cardiovascular event < 12 weeks prior
•to recruitment.
•6.Subjects having known chronic, contagious infectious disease, such as
•active tuberculosis, Hepatitis B or C, or HIV.
•7. Subjects participating currently or 1 month prior to recruitment in any other
•clinical study
•8.Known hypersensitivity to any of the ingredients used in study drug
•9.Pregnant and Lactating females.
•10. Any other condition due to which patients are deemed to be unsuitable by
•the investigatorâ??s opinion for reason(s) not specifically stated in the exclusion

发起方

Ayurved Sanshodhan Vibhag