Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: N163 Beta Glucan: Name : N163 Beta Glucan
Dose : 2 sachets per day
Dosage : 60 days of treatment period
Instructions for use : Mix one sachet of product with water and consume 30 minut
Sponsors
NichiIn Bio Sciences Pvt Ltd
MediNippon Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged >=21 years of age, all genders inclusive; with diagnosis/history of MS. 2. Subjects who have been on the same treatment regimen for a minimum of three months prior to enrolment and are willing to not make major changes to their standard treatment regimen until the end of the treatment period. 3. Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period. 4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product. 2. Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible 3. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation. 4. Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study. 5. Subjects with CKD or other diseases that impair normal kidney function. 6. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication. 7. Females who are pregnant or lactating or planning to become pregnant during the study period. 8. Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation 9. Subjects, who in the opinion of the investigator are unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CRP : Improvement of â?¥10% from baseline 2. ESR : Improvement of â?¥10% from baseline 3. CD56 : Improvement of â?¥10% from baseline 4. CD16 + Immune Cells : : Improvement of â?¥10% from baseline 5. CD4: Improvement of â?¥10% from baseline 6. CD8 : Improvement of â?¥10% from baseline 7. CD3+ T Lymphocytes: Improvement of â?¥10% from baseline 8. CD19 +B Lymphocytes : Improvement of â?¥10% from baseline 9. IL6 : Improvement of â?¥10% from baseline 10. Gut Microbiota Metagenome Sequencing : Improvement from baseline in the stool sample analysis. Timepoint: Day 1, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurofilament Light Chain (NFL) : Improvement of â?¥10% in sNfl from baseline 2. Fetuin A : : Improvement â?¥10% from baseline 3. Expanded Disability Status Scale (EDSS) : Improvement of â?¥1 score from baseline Timepoint: 1. Neurofilament Light Chain (NFL) : Day 1, Day 60 2. Fetuin A : Day 1, Day 60 3. Expanded Disability Status Scale (EDSS) : Day1, Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactDr Preethy SP
Nichi-In Bio Sciences Pvt. Ltd.
Outcome results
None listed