| CTRI Number |
CTRI/2023/05/053308 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study on Beta Glucan on Patients with Psoriasis |
|
Scientific Title of Study
|
An Open Label Prospective Clinical Study to evaluate the effects of N-163 strain of Aureobasidium Pullulans Produced β 1,3-16 Glucans in modulating the immunity in patients with Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Nichi-In Bio Sciences Pvt. Ltd. |
| Address |
B6, 13, Zakariah Colony III St, Choolaimedu
Chennai 600 094, Tamil Nadu, INDIA
Chennai
TAMIL NADU
600094
India |
| Phone |
9444927694 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Nichi-In Bio Sciences Pvt. Ltd. |
| Address |
B6, 13, Zakariah Colony III St, Choolaimedu
Chennai 600 094, Tamil Nadu, INDIA
Chennai
TAMIL NADU
600094
India |
| Phone |
9444927694 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preethy SP |
| Designation |
Trial Coordinator |
| Affiliation |
Nichi-In Bio Sciences Pvt. Ltd. |
| Address |
B6, 13, Zakariah Colony III St, Choolaimedu
Chennai 600 094, Tamil Nadu, INDIA
Chennai
TAMIL NADU
600094
India |
| Phone |
9444927694 |
| Fax |
|
| Email |
drspp@nichimail.jp |
|
|
Source of Monetary or Material Support
|
| M/s GN Corporation Co., Ltd.
3-8 Wakamatsu, Kofu,
Yamanashi Prefecture 400-0866, JAPAN. |
|
|
Primary Sponsor
|
| Name |
Nichi-In Bio Sciences Pvt. Ltd |
| Address |
B6, 13, Zakariah Colony III St, Choolaimedu
Chennai 600 094, Tamil Nadu, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MediNippon Healthcare Pvt Ltd |
No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094,
Tamil Nadu, INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thadeus J |
Govt. Thoothukudi Medical College |
Room No 1,
Department of Dermatology
Kamaraj Nagar, 3rd Mile,
Thoothukudi – 628 008.
Toothukudi
TAMIL NADU |
8184714894
ncrm.in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt Thoothukudi Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N-163 beta glucan |
- Standard Therapy + N-163 beta glucan
- 2 sachets of 16g gel per day
- 90 days of treatment duration |
| Comparator Agent |
Standard Therapy Only |
- Standard Therapy only
- 90 days of treatment duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- C Reactive Protein
- Tumor Necrosis Factor
- Interleuken 2
- Interleuken 6
- Interleuken 17
- 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
|
| Outcome |
TimePoints |
- 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 receptor |
- Baseline & End of Study
- Baseline & End of Study
- Baseline & End of Study
- Baseline & End of Study
- Baseline & End of Study
- Baseline & End of Study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil. None. Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 glucanPrimary 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 a
chronic, immune-mediated skin inflammatory condition in which the number and
location of skin lesions and comorbidities such psoriatic arthritis have
profound negative effects on the quality of life of the affected patients. The
achievement of psoriasis clearance or near clearance is a need for therapeutic
success, and this best correlates with an increase in quality of life Treatments
include conventional topical medications, oral medications, biological, and
oral small molecules. IL-6 has been linked to the etiology of psoriasis for
over 25 years. Purpose of the study
N-163 beta
glucan has potent anti-inflammatory activities which has been proven in animal
and human clinical studies. In an animal study of obese diabetic mice model of
KK-Ay mice, N-163 beta glucan was able to regulate the levels of non-esterified
fatty acids (NEFA) in 28 days. NEFA is
associated with metabolic syndrome induced inflammation and
altered NEFA composition in immune cell
membranes has been shown to influence immune cell functions possibly
contributing to the positive correlations between these fatty acids and MS
disease outcome |