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

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

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•1.Male or Female Subjects in the age group of 18 to 60 years, both inclusive.
•2.Subjects with confirmed patients of dermatitis with lesion size atleast 2cms.
•3.Subjects with Eczema having area severity score of 1.
•4.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
•5.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 eczema 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 case of any active malignancy.
•4.Cases of chronic origin.
•5.Lesions of large surface area.
•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 medical or surgical condition considered unsuitable for subject participation in the study as per Investigator judgment.
•11.Subject has H/O keliod formation following skin injury, severe dermatitis requiring systemic corticosteroids.

发起方

Ayurved Sanshodhan Vibhag