CTRI/2019/08/020618
Not yet recruiting
Phase 2
An open label, prospective, phase II, clinical study to evaluate efficacy and safety of Barphani Ointment in patients suffering from Eczema.
Ayurved Sanshodhan Vibhag0 sites0 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ayurved Sanshodhan Vibhag
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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