Health Condition 1: G319- Degenerative disease of nervous system, unspecified
Conditions
Interventions
None listed
Sponsors
THREE H 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. 4. Literate subjects. 5. 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. 6. Diagnosed psychiatric disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder. 7. Those consuming drugs amitriptyline, Aripiprazole, Benztropine, Biperiden, Brompheniramine, Carbamazepine, Chlorpheniramine, Chlorpromazine that affect cognitive performance like within 3 months prior to screening. 8. Those who are unable to communicate daily due to impaired vision, hearing, and unable to write due to physical disability. 9. Those who are taking drugs including antihistamine, non-steroid anti-inflammation, hormonal drugs, anti-biotics, etc. 10. Those who have undergone surgery within 6 months prior to screening. 11. Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (Angina pectoris, myocardial infarction, 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 investigatorâ?? discretion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes from pre- & post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA). 2.Change from pre- & post-treatment on cognitive function assessed by Alzheimerâ??s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).Timepoint: 1. Baseline and Week 12 2. Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in pre - & post-treatment Brain Derived Neurotrophic Factor. 2. Changes from pre- & post-treatment as assessed by individual tasks in Alzheimerâ??s Disease Assessment Scale â?? 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: 1. Baseline and Week 12 2. Baseline and Week 12 | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt. Ltd.
Outcome results
None listed