Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
Intervention1: Test Product: KSM 66 Ashwagandha Capsule
(300 mg), twice a day for 8
weeks
Control Intervention1: Control Product: 300 mg Placebo capsule
identical to KSM 66
Ashwagandha but without act
Sponsors
D Y Patil Medical College Hospital and Research Center
Eligibility
Inclusion 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 the trial.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Computerised Mental Performance Assessment System (COMPASS) Timepoint: week 0 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavior Rating Inventory of Executive Function®â??Adult Version (BRIEF-A)Timepoint: week 0 and week 8;Mental Fatigue â?? Mental Fatigue Scale (MFS)Timepoint: week 0 and week 8;Profile of Mood States (POMS, abbreviated version) Timepoint: week 0 and week 8 | — |
Countries
India
Contacts
Public ContactDr Deepak Langade
D Y Patil Medical College, Hospital and Research Center
Outcome results
None listed