Health Condition 1: null- Moderate to severe Psoriasis
Conditions
Interventions
Intervention1: SPHIRA: Duration 3 months Dose 2 tablets twice a day
Control Intervention1: Placebo: Duration 3 months. Dose 2 tablets twice a day
Sponsors
Nicholas Piramal Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of 18- 70 years of age. 2.Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months. 3.Subjects with plaque psoriasis having PASI score >10 even after at least one month treatment with topical steroids or for 2 months with other topical agents used in the treatment of psoriasis. 4.Women of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to entry into study, during the period of study participation and for at least 4 weeks after withdrawal from the study 5.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol-specific procedures are performed.
Exclusion criteria
Exclusion criteria: 1.Subject who has received systemic therapy such as Methotrexate or Cyclosporin therapy in the past three months prior to randomization. 2.Subject who have received TNF alpha inhibitor therapy any time in the past prior to screening. 3.Subjects with spontaneously improving or rapidly deteriorating plague psoriasis, acute guttate psoriasis, pustular, inverse or erythrodermic psoriasis, Psoriatic arthritis. 4.Subject with history of cancer including skin cancer. 5.Subject with serious dermatological infection in past three months requiring systemic therapy. 6.Any condition for which participation in this study as judged by the Investigator to be detrimental to the patient, such as (but not limited to) history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric diseases 7.Subject who has uncontrolled hypertension, severe cardiovascular, pulmonary, (specially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease. 9.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs 10.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month, three months prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.PASI score- change in PASI score at V4 (wk 12) compared to baseline 2.Physicianâ??s Global Assessment (PGA)- Change in PGA at V2 (wk 4), V3 (wk 8) and V4 (wk12), early termination visit compared to baseline 3.Photograph of the target lesionTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CRP level 2.Histopathological evaluation 3.Gene expression profile 4.ImmunohistochemistryTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Himanshu Parikh
Outcome results
None listed