None listed
Conditions
Sponsors
AP Organics Limited
Eligibility
Inclusion criteria
Inclusion criteria: i. Age above 18 years ii. Healthy participants (health status confirmed by clinical history, Physical Exam and routine blood analysis) from both gender iii. Participant must not have taken any vitamin / mineral/ dietary or herbal supplements, 1 month prior to enrolling in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion. iv. Participant must be able, willing and likely to fully comply with study procedures and restrictions. v. Participant must be literate or have a basic primary education. vi. Participant willing to sign the informed consent
Exclusion criteria
Exclusion criteria: Evidence of renal disease (S. Creatinine > 1.5mg/ml) Evidence of liver disease (AST/ALT >3 times of normal) Pregnant and lactating mothers intending pregnancy History of alcohol intake and smoking Participation in any other clinical trial within the last 30 days. History of intake of dietary supplements or immunomodulatory drugs. Participants taking rice bran oil in their diet regularly. History of intolerance or hypersensitivity to gamma oryzanol. Clinically diagnosed with alzheimers disease. Prior history of stroke, dementia, Parkinsons disease, fibromyalgia, multiple sclerosis, epilepsy or other known diseases that affect memory or cognition Taking any medicines that are stimulants including amphetamine, methylphenidate, atomoxetine hydrochloride, or lisdexamfetamine dimesylate. GI disorders known to impair absorption of nutrients. Traumatic brain injury in personal history. Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to gamma-oryzanol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in baseline value of Th1 and Th2 cytokines (IFN-gamma, IgA, IgG, IgM and IgE between the groups. Changes in baseline counts of T-cell, B-cell, TNF-alpha, NK-cells, IL-2, IL-4, IL-6 between the groups Mean percent changes in baseline values of serum cortisol and CRP levels between the groups. Eriksen flanker task The Mackworth clock test Wisconsing Card Sorting Test Mental rotation task ACE-III Trail Making Test (TMT)Timepoint: Outcome will be assessed after 60days treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the adverse drug reactions in both group Improvement from baseline in the Index scores of immediate memories, general memory, working memory, attention and fluency in language after therapy, and visual-spatial skills and task switching after therapy. Mean percent changes between gamma-oryzanol and placebo trial arms from baseline to 60 days as in: a. Basic vital signs b. Liver function tests c. Kidney function tests d. Thyroid function tests e. Lipid profile Timepoint: ADR monitoring will be throughout the study duration, rest of the parameters will be assessed on 0 and 60th day of the treatment | — |
Countries
India
Contacts
Public ContactDr Shital Panchal
Institute of Pharmacy Nirma University
Outcome results
None listed