None listed
Conditions
Interventions
None listed
Sponsors
3H LABS Co. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).Timepoint: Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in pre - & post-treatment Brain Derived Neurotrophic Factor.Timepoint: 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.Timepoint: Baseline and Week 12 | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt. Ltd.
Outcome results
None listed