Clinical Trial on WEL/PSO-01 Capsules in Psoriasis.
- Conditions
- Health Condition 1: null- Chronic Plaque Psoriasis
- Registration Number
- CTRI/2018/03/012615
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months
2. Subjects with plaque psoriasis having PASI score more than 10.
3. 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 more than 2 years postmenopausal.
4. 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 or Chronic hepatic or renal disease.
4. Known case of any active malignancy.
5. Subjects giving history of significant cardiovascular event less than 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 criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of changes in PASI Score. <br/ ><br>2. Assessment of Clinical Photographic changes in psoriasis lesions (Scaling, Intensity and Thickness) <br/ ><br>Timepoint: Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120
- Secondary Outcome Measures
Name Time Method 1. Assessment of quality of life on Dermatology Life Quality Index <br/ ><br>2 Assessment of change in Overall Disease Severity <br/ ><br>3 Assessment of Changes in Pruritus Score <br/ ><br>4 Assessment of relapse of Psoriasis <br/ ><br>5 Assessment of Adverse Drug Reaction and post-treatment clinically significant abnormal laboratory parameters. <br/ ><br>6 Physicianâ??s and subjectâ??s Global Assessment for overall change at the end of study. <br/ ><br>7 Global assessment of overall safety of WEL/PSO-01 as per subject and physician.Timepoint: Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120