A study to evaluate the efficacy
of Withania somnifera extract on cognitive function.
Scientific Title of Study
A randomized, double-blind, placebo controlled, parallel study to evaluate the efficacy and safety of Withania somnifera extract on cognitive function.
Department of General Medicine, Room No. 6,7and 8, 18th Cross,4th main, Near Margosa Road BMTC Bus stand,
Malleswaram west, Bangalore
Bangalore KARNATAKA
1. Male and Female individuals aged from 55 to 80 years (both inclusive).
2. Without hearing, visual impairment and other communication disorders.
3. Those who meet the requirement of Montreal Cognitive Assessment Score of 19 to 25 (both inclusive).
4. Literate subjects.
5. Individuals who do not meet the definition of dementia according to the Diagnostic and Statistical Manual Disorders (DMS).
6. Those who voluntarily agree to participate and sign the informed consent form.
ExclusionCriteria
Details
1. Known history of hypersensitivity to any drugs, herbal extracts or dietary supplements.
2. Those with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding 3 months or are currently ongoing.
3. On-going treatment with herbals or allopathic drugs(cholinesterase inhibitors) for MCI.
4. History of seizures.
5. Head trauma with loss of consciousness within 6 months prior to screening.
6. Diagnosed psychiatric disorders or other serious mental illness,
including severe depression, dissociative disorder, obsessive compulsive disorder, personality disorders, schizophrenia, bipolar disorder, cognitive impairment due to brain disease.
7. Those consuming drugs such as acetylcholinesterase inhibitor, neuroprotective agents, thyroid hormones, central nervous system stimulants, anticholinergic agents, antidepressant, antianxiety etc. that affect cognitive performance within 3 months prior to screening.
8. Those consuming supplements including Withania somnifera other than IP, Dendropanax morbiferus, Gastrodia elata, Enzyme-Treated Tremella fuciformis, Aster glehni, Angelica gigas, Panax ginseng C.A. Meyer sprout, Spirulina, Scrophularia buergeriana, Heat treated green tea extract, Sesame Oil Cake
Extract, Mixture complex of Grape and blueberry powder, Gastrodia combination extract, Lycium chinense Fruit, Eriobotrya Leaf Extract, Fermented Sea Tangle, Silk Fibroin Peptide, Polygala tenuifolia Willdenow root, Saururus chinensis Baill, Schisandra chinensis, and other cognitive related supplements within 3 months prior to screening.
9. Those who are unable to communicate daily due to impaired vision, hearing, and unable to write due to physical disability.
10. Those who are taking drugs including antihistamine, non-steroid
anti-inflammation, hormonal drugs, anti-biotics, etc. for more than 2 weeks within 4 weeks prior to screening
11. Those who have undergone surgery within 6 months prior to screening.
12. Those with severe cerebrovascular disease (cerebral infarction,
cerebral hemorrhage, acute ischemic stroke, transient ischemic attack, etc.), heart disease (angina pectoris, myocardial infarction, coronary intervention including bypass grafting, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial on the investigator’s discretion).
13. Those with a serious dysfunction of the liver (alanine and
aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine greater than 2.0 mg/dL).
14. Those with hypertension (blood pressure greater than or equal to 140/90 mmHg), mellitus diabetes or HbA1c greater than 7.0 percentage, or hypothyroidism
15. Those with diagnosis of malignant tumor diagnosed within 3 years prior to screening.
16. Had weight gain or weight loss of more than 5 kg within 3 months
before screening.
17. History of drug and alcohol dependence or substance-related disorders
18. Have high daily alcohol consumption, i.e. more than 360ml/bottle or
14 bottles of beer (350 ml/bottle) per week.
19. Those who are pregnant or lactating, childbearing age who do not agree to use contraception during the trial
20. Those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
1. Changes from pre- and post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA).
2. Changes from pre- and post-treatment on cognitive function assessed by Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
Baseline and Week 12
Secondary Outcome
Outcome
TimePoints
1. Changes in pre - & post-treatment Brain Derived Neurotrophic
Factor.
Baseline and Week 12
2. Changes from pre- and post-treatment as assessed by individual tasks in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) including 1) Word Recall, 2) Commands, 3) Constructional Praxis, 4) Naming, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Remembering Word Recognition Test Instructions, 9) Comprehension of Spoken Language, 10) Word-Finding Ability, and 11) Spoken Language Ability.
Baseline and Week 12
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
10/06/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Cognitive function refers to a range of brain activities involved in acquiring, processing, and reasoning with information. As individuals age, cognitive function often declines, potentially leading to mild cognitive impairment (MCI)—a condition marked by reduced cognitive abilities without significant disruption to daily life (Sabbagh et al.). Individuals with MCI are at an elevated risk of progressing to dementia-related conditions, such as Alzheimer’s disease . To address this growing issue, it is essential for healthcare providers to assess MCI using reliable methodologies at an early stage and recommend appropriate interventions.
Withania somnifera (WS), commonly known as Ashwagandha, has been well recognized as a ‘Rasayana’ in Ayurveda, signifying its role in promoting longevity and vitality. Its long standing use in traditional medicine highlights not only its therapeutic benefits but also its safety profile. Over centuries, Ashwagandha has been utilized to enhance physical and mental health with minimal reported adverse effects. Modern research supports its safe use, noting its generally well-tolerated nature, even in long-term applications. Clinical studies have further demonstrated its adaptogenic properties without significant toxicity, reinforcing its reputation as a safe and effective herbal remedy.