Clinical Trial on WEL/PSO-01 Capsules in Psoriasis.
- Conditions
- Chronic Plaque Psoriasis
- Registration Number
- CTRI/2018/03/012615
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Itis an open label, single arm, multi-center, prospective, clinical study to evaluateefficacy and safety of WEL/PSO-01 in patients suffering from chronic plaque psoriasis. The study will be conducted at three sites inIndia. Subjects will beadvised to take 2WEL/PSO-01 Capsules twice daily orally after meals for 3 months (90 days).After 3 months of treatment, subjects will be asked to come for follow ups after1 month to observe relapse / recurrence of psoriasis symptoms. The primary objective of study is to evaluate changesin PASI Score and clinical Photographic changes in psoriasis lesions (Scaling,Intensity and Thickness). The secondary objectives will be assessment of qualityof life on Dermatology Life Quality Index, assessment of change in OverallDisease Severity, assessment of Changes in Pruritus Score on the VisualAnalogue Scale, assessment of relapse of Psoriasis after 30 days of cessationof treatment, assessment of Adverse Drug Reaction and post-treatment clinicallysignificant abnormal laboratory parameters, physician‘s and subject‘s GlobalAssessment for overall change at the end of study and global assessment ofoverall safety of WEL/PSO-01 as per subject and physician
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months 2.
- Subjects with plaque psoriasis having PASI score more than 10.
- 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.
- Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
- 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.
- Any laser dermatological procedure, 4 weeks prior to screening in this study.
- Known cases of Severe or Chronic hepatic or renal disease.
- Known case of any active malignancy.
- Subjects giving history of significant cardiovascular event less than 12 weeks prior to recruitment.
- Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subjects participating currently or 1 month prior to recruitment in any other clinical study.
- Known hypersensitivity to any of the ingredients used in study drug.
- Pregnant and Lactating females.
- Any other condition due to which patients are deemed to be unsuitable by the investigator‘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. Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120 2. Assessment of Clinical Photographic changes in psoriasis lesions (Scaling, Intensity and Thickness) 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 2 Assessment of change in Overall Disease Severity
Trial Locations
- Locations (4)
Ayurveda Research Center Ayurved Seva Sangh Ganeshwadi Nashik
🇮🇳Nashik, MAHARASHTRA, India
College of Gomantak Ayurved Mahavidyalay & Research Centre Shiroda Goa
🇮🇳Goa, GOA, India
National Institute of Ayurveda Jaipur
🇮🇳Jaipur, RAJASTHAN, India
PDEAs College of Ayurvedic and Research Centre, Nigdi
🇮🇳Pune, MAHARASHTRA, India
Ayurveda Research Center Ayurved Seva Sangh Ganeshwadi Nashik🇮🇳Nashik, MAHARASHTRA, IndiaDr Abhay N KulkarniPrincipal investigator7774844739abhaynk@yahoo.com