Clinical Study on Beta Glucan on Patients with Psoriasis

An Open Label Prospective Clinical Study to evaluate the effects of N-163 strain of Aureobasidium Pullulans Produced Î² 1,3-16 Glucans in modulating the immunity in patients with Psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053308

Enrollment

Registered

2023-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: N-163 beta glucan: - Standard Therapy + N-163 beta glucan - 2 sachets of 16g gel per day - 90 days of treatment duration Control Intervention1: Standard Therapy Only: - Standard Therapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and females at least 18 years of age. 2. Except for plaque psoriasis with or without arthritis, subject is in generally good health. 3. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis ( > 5% body surface area (BSA) involvement). 4. Signed, written informed consent 5. Willing and able to comply with study visits according to protocol for the full study period

Exclusion criteria

Exclusion criteria: 1. Patients with forms of psoriasis other than chronic plaque-type psoriasis or with drug-induced psoriasis 2. Use of an investigational drug within 90 days prior to Day 1. 3. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results 4. Patient with any active or chronic infection 5. Pregnancy or risk of pregnancy. 6. Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C 7. Patients unable to give written informed consent

Design outcomes

Primary

Measure	Time frame
- C Reactive Protein - Tumor Necrosis Factor - Interleuken 2 - Interleuken 6 - Interleuken 17 - Inteleuken 12Timepoint: - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study	—

Secondary

Measure	Time frame
- Improvement in patient symptoms - Physicians Evaluation of Plaque Severity - PASI 75 - PASI 50 - 5 Point Reduction in DLQI - Skin Biopsy : H& E Staining & Immunohistochemistry for TNF alpha, IL6, IL17, VEGFR2, Prolactin receptorTimepoint: - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study - Baseline & End of Study	—

Countries

India

Contacts

Public ContactDr Preethy SP

Nichi-In Bio Sciences Pvt. Ltd.

drspp@nichimail.jp9444927694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026