Clinical Study on Beta Glucan on Patients with Psoriasis

Phase 3

Not yet recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2023/05/053308
• Lead Sponsor: Nichi-In Bio Sciences Pvt. Ltd

Brief Summary

**Study Design :** An Open Label, Prospective, Clinical Study **Treatment Arms : II Treatment Arms Treatment I :** Standard Therapy + n-163 beta glucan **Treatment II :** n-163 beta glucan

**Primary Outcome Measures -** C Reactive Protein - Tumor Necrosis Factor - Interleuken 2 - Interleuken 6 - Interleuken 17 - Inteleuken 12 **Secondary Outcome Measures** - Improvement in patient symptoms - Physician’s 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 receptor **Background of the study** Psoriasis is achronic, immune-mediated skin inflammatory condition in which the number andlocation of skin lesions and comorbidities such psoriatic arthritis haveprofound negative effects on the quality of life of the affected patients. Theachievement of psoriasis clearance or near clearance is a need for therapeuticsuccess, and this best correlates with an increase in quality of life Treatmentsinclude conventional topical medications, oral medications, biological, andoral small molecules. IL-6 has been linked to the etiology of psoriasis forover 25 years.

**Purpose of the study** N-163 betaglucan has potent anti-inflammatory activities which has been proven in animaland human clinical studies. In an animal study of obese diabetic mice model ofKK-Ay mice, N-163 beta glucan was able to regulate the levels of non-esterifiedfatty acids (NEFA) in 28 days. NEFA  isassociated with metabolic syndrome induced inflammation   andaltered NEFA  composition in immune cellmembranes has been shown to influence immune cell functions possiblycontributing to the positive correlations between these fatty acids and MSdisease outcome

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-30
• Study Start: 2023-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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.
• 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.
• Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C 7.
• Patients unable to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- C Reactive Protein	- Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study
- Tumor Necrosis Factor	- Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study
- Interleuken 2	- Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study
- Interleuken 17	- Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study
- Interleuken 6	- Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study | - Baseline & End of Study
- Inteleuken 12	- 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 Outcome Measures

Name	Time	Method
- Improvement in patient symptoms	- Physicians Evaluation of Plaque Severity

Trial Locations

Locations (1)

Govt. Thoothukudi Medical College; 🇮🇳 Toothukudi, TAMIL NADU, India

Govt. Thoothukudi Medical College

🇮🇳Toothukudi, TAMIL NADU, India

Dr Thadeus J

Principal investigator

8184714894

ncrm.in@gmail.com