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Clinical Trials/CTRI/2021/10/037029
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

Sponsor
D Y Patil Medical College Hospital and Research Center

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