Health Condition 1: null- Chronic Plaque Psoriasis
Conditions
Interventions
Intervention1: WEL/PSO-01 Capsule: WEL/PSO-01 Capsule contains Acacia catechu, Holarrhena antidysenterica, Azadirecta indica, Smilax china, Swertia chirata, Posoralea coryfolia, Picrorhiza kurroa, He
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in PASI Score. 2. Assessment of Clinical Photographic changes in psoriasis lesions (Scaling, Intensity and Thickness) Timepoint: Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of quality of life on Dermatology Life Quality Index 2 Assessment of change in Overall Disease Severity 3 Assessment of Changes in Pruritus Score 4 Assessment of relapse of Psoriasis 5 Assessment of Adverse Drug Reaction and post-treatment clinically significant abnormal laboratory parameters. 6 Physicianâ??s and subjectâ??s Global Assessment for overall change at the end of study. 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 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed