To study the effect of Ashwagandha extract on Memory

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050974

Enrollment

Registered

2023-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ashwagandha extract: one capsule of 250 mg, once daily for 60 days Control Intervention1: Placebo: One capsule of 250 mg, once daily for 60 days

Eligibility

Inclusion 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 7. Mini-Mental State Examination (MMSE) score 20-23 8. Vitamin B12 (Serum) 200-900pg/mL

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Wechsler Memory Scale â??III (WMS-III) Score Shepard Mental Rotation Task Score Timepoint: Baseline, Day 30, Day 60	—

Secondary

Measure	Time frame
Montreal Cognitive Assessment (MoCA) Mini-mental state examination (MMSE)Timepoint: Baseline, Day 30, Day 60	—

Countries

India

Contacts

Public ContactDr Giby Abraham

Arjuna Natural Private Limited

drbinu@arjunanatural.com09447818432

Outcome results