Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: AFO 202 Beta Glucan: Name : N163 Beta Glucan
Dose : 3 sachets per day
Dosage : 90
days of treatment period
Instructions for use : Mix one
sachet of product with water
and consume 30 m
Sponsors
NichiIn Bio Sciences Pvt Ltd
MediNippon Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged >=18 years, diagnosed with Parkinsonâ??s Disease 2. Subjects with Parkinsonâ??s Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinsonâ??s Disease Association of the United Kingdom. 3. 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. 4. Subject/Caregiver/LAR who will be answering the evaluation questions must have the basic computer literacy to be able to use Google Forms 5. Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period. 6. 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 advanced stage disease 2. Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product. 3. Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible 4. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation. 5. Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study. 6. Subjects with CKD or other diseases that impair normal kidney function. 7. 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. 8. Females who are pregnant or lactating or planning to become pregnant during the study period. 9. Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation 10. Subjects, who in the opinion of the investigator are unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Unified Parkinsonâ??s Disease Rating Scale (UPDRS) : Reduction of â?¥5 scores from baseline 2. The Clinical Global Impressions Improvement Scale (Based on Magnetic Resonance Imaging) : Score of â?¤3 at end of study. 3. Levodopa equivalent dose treatment : Reduction of â?¥10% dose from baseline. 4. Constipation Severity Score : Reduction of â?¥10 scores from baseline. 5. α-synuclein : Improvement from baseline 6. Serum Neurofilament light chain : Improvement from baseline 7. Serum Creatinine Kinase : Reduction from baseline 8. Gut Microbiota Metagenome Sequencing : Improvement from baseline in the stool sample analysis. Timepoint: Day 1 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Only for Subjects with Diabetes Mellitus Type II 1. Fasting Blood Glucose : Improvement from baseline 2. Post Prandial Blood Glucose : Improvement from baseline 3. HbA1C : Improvement from baseline Timepoint: Day 1 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Preethy SP
Nichi-In Bio Sciences Pvt. Ltd.
Outcome results
None listed