CTRI/2023/03/050974CompletedPhase 1
A Randomized, Double Blind, Placebo Controlled Pilot Study to Evaluate the Effect of Ashwagandha (Withania somnifera) Extract in improving memory in adults with mild cognitive impairment
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Age between 25 to 65 years
- •2. Participants with mild, subjective symptoms of memory impairment
- •3. Participants with no impairment in Social and Occupational Functioning
- •4. Instrumental Activities of Daily Life (IADL) score > 6
- •5. Montreal Cognitive Assessment (MoCA) Score 18-25
- •6. Clinical Dementia Rating (CDR) Global score < 0.5
- •7. Mini-Mental State Examination (MMSE) score 20-23
- •8. Vitamin B12 (Serum) 200-900pg/mL
Exclusion Criteria
- •1. Known neuropsychiatric conditions including depression
- •2. Persistent endocrine disorders
- •3. Uncontrolled hypertension
- •4. Diabetes mellitus
- •5. Drug dependence or addiction
- •6. Use of alcohol
- •7. Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition.
- •8. Pregnant or lactating women and
- •9. Subjects with known hypersensitivity to ashwagandha
- •10. Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study.
- •11. History of significant brain disorders (e.g., stroke or epilepsy);
- •12. Use of any type of dementia-delaying medication;
- •13. Head trauma with post-traumatic loss of consciousness for at least 30 min during the lifespan
- •14. Brain damaged patients (brain tumour; penetrating head injury; closed head injury; cerebral vascular accident; cerebral abscess; cerebral atrophy; subdural hematoma; temporal lobectomy for epilepsy; dementia paralytica; congenital anomaly of brain)
Investigators
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