A study to evaluate the efficacy of Withania somnifera extract on cognitive function.

Not yet recruiting

• Conditions: Mild cognitive impairment

• Registration Number: CTRI/2025/05/086278
• Lead Sponsor: 3H LABS Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-22
• Study Start: 2025-10-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Male and Female individuals aged from 55 to 80 years (both inclusive).
• 3.Those who meet the requirement of Montreal Cognitive Assessment Score of 19 to 25.
• 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.

Exclusion Criteria

• Known history of hypersensitivity to any drugs, herbal extracts or dietary supplements.
• 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.
• On-going treatment with herbals or allopathic drugs(cholinesterase inhibitors) for MCI.
• History of seizures.
• Head trauma with loss of consciousness within 6 months prior to screening.
• 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.
• 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..
• 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.
• Those who are unable to communicate daily due to impaired vision, hearing, and unable to write due to physical disability.
• 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.
• 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 bypassgrafting, 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).
• 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 per dL).
• Those with hypertension (blood pressure greater than or equals 140 per 90 mmHg), mellitus diabetes or HbA1c greater than 7.0 percent, or hypothyroidism 15.
• Had weight gain or weight loss of more than 5 kg within 3 months before screening.
• History of drug and alcohol dependence or substance-related disorders 18.
• Have high daily alcohol consumption, i.e. more than 360ml per bottle or 14 bottles of beer (350 ml per bottle) per week.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
1. Changes from pre- and post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA).	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
1. Changes in pre - & post-treatment Brain Derived Neurotrophic	Factor.
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

Trial Locations

Locations (1)

Vagus Super Speciality Hospital Pvt.Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Vagus Super Speciality Hospital Pvt.Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Venkatesh S

Principal investigator

9738226474

venkateshsmysore7@gmail.com