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Clinical Trials/CTRI/2019/08/020504
CTRI/2019/08/020504
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 Chronic Plaque Psoriasis.

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
  • 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.

Exclusion Criteria

  • 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.

Investigators

Sponsor
Ayurved Sanshodhan Vibhag

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