Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Group A [Sorozema capsule (oral) + Sorozema oil (Topical)]: One Sorozema capsule twice daily morning and evening after food for 120 days. Sorozema topical oil 2 5 mL or as required to c
Sponsors
Nisarga Biotech Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participants aged 30 to 60 years inclusive. 2.A confirmed diagnosis of plaque psoriasis for at least 6 months involving the skin, scalp, or both, For group B the application of cream to scalp will not be recommended. 3.Participants diagnosed with plaque psoriasis with a PASI score must be between 3-20 both inclusive mild to moderate chronic plaque psoriasis. Participants who have previously received topical corticosteroids or other topical antipsoriatic agents, provided they have completed the required washout period prior to randomization 2 weeks for topical corticosteroids and vitamin D analogs. 4.Participants who have not received systemic antipsoriatic therapy example methotrexate, cyclosporine, systemic corticosteroids, apremilast, or biologics within the required washout period prior to randomization typically 4 weeks for systemic corticosteroids and conventional systemic therapies 8 16 weeks for biologics. 5.Women of childbearing potential and men must agree to use adequate contraception hormonal or barrier methods, or abstinence before entering the study, during participation, and for at least 4 weeks after study withdrawal. 6.Ability to understand and willingness to sign a written informed consent document at the screening visit before any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1.Prior use of TNF-alpha inhibitor therapy at any time before screening. 2.Presence of spontaneously improving or rapidly worsening plaque psoriasis, or diagnosis of acute guttate, pustular, inverse, or erythrodermic psoriasis, or psoriatic arthritis. 3.History or presence of any malignancy, including skin. 4.Serious dermatological infection within the past 3 months that required systemic therapy. 5.Any condition deemed by the investigator to pose risk or be detrimental to participation including but not limited to uncontrolled hypertension or severe cardiovascular, pulmonary (especially chronic obstructive pulmonary disease requiring steroid therapy), cerebral, hematologic, gastrointestinal, neurological, or psychiatric disorders. 6.Current use of medications known to worsen psoriasis, including Lithium, beta-blockers, antimalarials, or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). 7.Continuous use of Ayurvedic, Homeopathic, or Herbal products for at least 1 month, within the 3 months prior to screening. 8.Pregnant or lactating women. 9.History of substance abuse or heavy use of alcohol, drugs, or tobacco; 10.Any other condition, at the discretion of the investigator, that may interfere with the study results or compromise participant safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 the efficacy of the investigational products in improving psoriasis severity, symptoms, and quality of life and visual improvement through images.Timepoint: 1.From screening to day 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in sleep-by-sleep quality questionnaire. 2.Changes in TNF alpha levels. 3.Change in Perceived stress scale (PSS) questionnaire score. 4.Assessment of Overall Improvement by participant and investigator. 5.Adverse events profile 6.Compliance and tolerability of the investigational productTimepoint: 1.At screening and day 120. 2.At screening and day 120. 3.At screening and day 120. 4.Day 120. 5.At baseline, day 30, day 60, day 90 and day 120. 6.At baseline,day 30, day 60, day 90 and day 120. | — |
Countries
India
Contacts
Public ContactDr Arati Devendra Soman
Sonark Pharmaceuticals Pvt. Ltd
Outcome results
None listed