Clinical Study to Evaluate the Efficacy and Safety of Psorolin Oil in comparison with Combined Therapy of 777 oil, Psorolin Bathing Bar,Psorolin Oil and Psorolin Ointment in Adult Subjects with Moderate to Severe Psoriasis.
- Conditions
- Health Condition 1: L409- Psoriasis, unspecified
- Registration Number
- CTRI/2014/10/005143
- Lead Sponsor
- Dr JRKs Siddha Research and Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1.Male and Female Adults between the ages of 18 and 50 years (both ages inclusive)
2.Psoriasis Body Surface Area at baseline is >3%
3.Subject w ho understand and willing to sign informed consent document before start of any study specific assessment.
4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
5.Subject has not participated in a similar investigation in the past four weeks.
1.Subjects with Psoriatic Arthritis.
2.Ongoing topical treatment or remedial measures for psoriasis inclusive of creams, lotions and oils 2 weeks before inclusion into the study.
3.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs or using corticosteroids and anti-inflammatory medicines until 15 days before inclusion into the study.
4.Subjects are using DMARDS or are on Psoralen+UVA - Phototherapy 4 weeks prior to inclusion into the study.
5.Subject with history of cancer including skin cancer.
6.Subject with serious dermatological infection in past three months requiring systemic therapy.
7.Subjects with facial melasma, lesions and other types of skin damage that is not psoriasis.
8.History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection.
9.History of opportunistic infections (e.g., systemic fungal infections, parasites)
10.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease or any other serious medical illness.
11.A known history or present condition of allergic response to any cosmetic products.
12.Females who are pregnant or lactating or planning to become pregnant during the study period.
13.Subjects who maybe allergic to any of the natural constituents of the Investigational Product.
14.Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method