To study the effect of Ashwagandha extract on Memory

Phase 1

Completed

• Registration Number: CTRI/2023/03/050974
• Lead Sponsor: Arjuna Natural Private Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wechsler Memory Scale â??III (WMS-III) Score <br/ ><br>Shepard Mental Rotation Task Score <br/ ><br>Timepoint: Baseline, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA) <br/ ><br>Mini-mental state examination (MMSE)Timepoint: Baseline, Day 30, Day 60