CTRI/2021/10/037029Completed未知
Effects of KSM-66® on memory, attention, executive function, and sleep in adults: a randomised, double-blind, placebo-controlled study
D Y Patil Medical College Hospital and Research Center0 sites80 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Healthy adults (male and female) between 30 and 75 years
- •2. Residing in independent living accommodation
- •3. Subjective report of memory or attention problems by answering â??yesâ?? to the following question: Do you
- •have problems with your memory, attention, or concentration?
- •4. Subjective reports of fatigue/energy problems by answering â??yesâ?? to the following question: Do you have
- •problems with fatigue or energy?
- •5. Non-smoker
- •6. BMI between 18 and 35 kg/m2
- •7. No plan to commence new treatments over the study period
- •8. Understand, be willing, and able to comply with all study procedures
- •9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of
Exclusion Criteria
- •. A score below the 5
- •th percentile for age, education, and gender on the Telephone Interview for Cognitive
- •Status (TICS-M)
- •2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to:
- •diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of
- •medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease,
- •acute or chronic pain condition
- •3. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other
- •than mild-to-moderate depression or anxiety), neurological disease (Parkinsonâ??s, Alzheimerâ??s disease,
- •intracranial haemorrhage, head or brain injury), or cancer/malignancy
- •4. History of stroke or seizures or head injury (with loss of consciousness).
- •5. Regular medication intake including anti-coagulant drugs, anti-cholinergics, acetylcholinesterase
- •inhibitors, or steroid medications.
- •6. Change in medication in the last 3 months or expectation to change during the study duration
- •7. Current nutrient deficiencies including low iron or vitamin B12 concentrations
- •8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
- •9. Current or 12-month history of illicit drug abuse
- •10. Alcohol intake greater than 14 standard drinks per week
- •11. Any significant surgeries over the last year
Investigators
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