To study the effect of Ashwagandha extract on Memory

Phase 1/2

Completed

• Conditions: Mild cognitive impairment

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

Brief Summary

The study is designed to evaluate the effect of ashwagandha extract ti omprove memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test product or placebo. Participants will be assessed using memory scales at Baseline. The participants will be given investigational products for 60 days at a dose of 250mg/day. Memory assessment will be done after 30 and 60 days after intake of investigational products.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-04
• Last Update Posted: 2023-06-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.
• Vitamin B12 (Serum) 200-900pg/mL.

Exclusion Criteria

• 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.
• 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.
• 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 –III (WMS-III) Score	Baseline, Day 30, Day 60
Shepard Mental Rotation Task Score	Baseline, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	Mini-mental state examination (MMSE)

Trial Locations

Locations (1)

Hitech Hospital and Trauma Center; 🇮🇳 Jhansi, UTTAR PRADESH, India

Hitech Hospital and Trauma Center

🇮🇳Jhansi, UTTAR PRADESH, India

Dr Hari Prakash Rai

Principal investigator

9839684036

drhprai.neuro@gmail.com