None listed
Conditions
Interventions
Intervention1: Ashwagandha extract 125 mg: One capsule daily in the morning for 90 days
Intervention2: Ashwagandha extract 250 mg: One capsule daily in the morning for 90 days
Control Intervention1: P
Sponsors
Arjuna Natural Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female = 50 years of age with 1:1 ratio 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 greater than 6 5. Montreal Cognitive Assessment (MoCA) Score 18-25 6. Clinical Dementia Rating (CDR) Global score less than 0.5 7. Mini-Mental State Examination (MMSE) score 20-23 8. Vitamin B12 (Serum) 200-900pg/mL 9. Ability to follow all instructions in the study protocol and be willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known neuropsychiatric conditions including depression 2.Persistent endocrine disorders 3.Uncontrolled hypertension 4.Uncontrolled Diabetes mellitus 5.Hypothyroidism 6.Drug dependence or addiction 7.Alcohol dependence 8.Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition. 9.Pregnant or lactating women 10.Subjects with known hypersensitivity to ashwagandha 11.Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study. 12.History of significant brain disorders (e.g., stroke or epilepsy) 13.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) 14.Participant with a medical disorder, condition, or history such that could impair the participant’s ability to participate or complete this study in the opinion of the investigator. 15.Subjects who participated in a clinical trial for the past 3 months. 16.Unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in MOCATimepoint: Baseline, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in MMSE, MSQ, WHO-5Timepoint: Baseline, Day 30, Day 60, Day 90 ;Mean change in computerized cognitive tests assessedTimepoint: Baseline, Day 30, Day 60, Day 90;Mean change in Safety profile and BiomarkersTimepoint: Baseline, Day 90;Adverse event evaluationTimepoint: Throughout the study duration | — |
Countries
India
Contacts
Public ContactDr Giby Abraham
Arjuna Natural Private Limited
Outcome results
None listed