This study will be conducted to study the effectiveness as well as safety of AKBBA capsules and application cream in the management of the most common type of Psoriasis.
- Conditions
- Health Condition 1: null- Adult male or female patients with mild to moderate plaque type psoriasis.
- Registration Number
- CTRI/2018/04/012946
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1 Patients with Mild to Moderate plaque type psoriasis excluding co-morbid conditions.
2 Chronic plaque type psoriasis or stable psoriasis.
3 Willing to sign on Informed consent form.
1 Patients who have more than 50 percent of body surface area covered by psoriasis lesions.
2 Patients on anticoagulant therapy.
3 Use of immunosuppressive medication within past 2 months.
4 Presence of other skin lesions (actinic ketoses or lentigo) or photo damaged skin
5 Use of systemic or intra lesional therapy or photo (chemo) therapy for psoriasis in the previous two months.
6 Concomitant bacterial, fungal, or viral skin infections.
7 Pregnant or sexually active women who do not use contraception.
8 Non-adherence to the treatment.
9 Have history of renal, hepatobiliary, or malignant disease, hypertension or recurrent acute infection
10 History of any other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 PASI Scoring. <br/ ><br>2 Clinical Photographs. <br/ ><br>3 Global Evaluation by the Doctor. <br/ ><br>4 Global Evaluation by the Patient. <br/ ><br>5 Psoriasis global assessment. <br/ ><br>6 Biomarkers.Timepoint: 1 PASI Scoring,Global Evaluation by Doctor and Patient(Day0,Day30,Day60 & Day90). <br/ ><br>2 Clinical Photographs(Screening,Day0,Day30,Day60 & Day90). <br/ ><br>3 Biomarkers(Day0 & Day90).
- Secondary Outcome Measures
Name Time Method 1 Adverse Events.Timepoint: Day0,Day30,Day60 & Day90.