Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere
Conditions
Interventions
Intervention1: Group I :Pinorox (Pine Bark Extract)
100 mg Capsule (Test Product)
: 100mg, Once a day, Oral for 6 months
Control Intervention1: Group II Placebo Capsule ( Comparator agent): 100mg, O
Sponsors
Ambe Phytoextracts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects aged, fifty to eighty years inclusive, with a body mass index ranging from 18.5 to 29.9 kilograms per square meter inclusive. 2.Subjects with complaints of cognitive decline. 3.Subjects who have a Mini Mental State Examination score between eighteen and twenty three inclusive. 4.Subjects and or legally acceptable representative who provide written informed consent to participate in the study. 5.Subjects who have the ability to comprehend the full nature and purpose of the study including possible risks and adverse events the ability to cooperate with the investigator and comply with the entire study requirements. 6.Subjects who are willing to use appropriate birth control methods throughout the duration of the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with psychiatric disorders (other than mild to moderate depression or anxiety with score greater than five on GDS SF with known neuropsychiatric conditions like Schizophrenia, Alzheimer s disease (AD) or Parkinsons s disease; Epilepsy, Mental retardation, Huntington s disease, Picks disease etc. 2.Subjects who meet the definition of dementia according to the Diagnostic and Statistical Manual of Mental Disorders V. 3.Subjects who had the following medications within four weeks prior to the consent date (i.e., Medications used to treat Dementia, Brain Metabolism enhancers, Central nervous system stimulants, Antipsychotics, Anticholinergics, Anticoagulants, Tricyclic Antidepressants, Anxiolytics, Nootropics, etc.). 4.Subjects who have taken health supplements related to the study function within three months prior to the start of the study. 5.Subjects with abnormal laboratory findings Alanine aminotransferase or aspartate aminotransferase levels are greater than three times the upper limit of normal, hemoglobin is less than or equal to 8.5g per deciliter or platelet count is less than one hundred thousand per cubic millimeter, and estimated glomerular filtration rate is less than sixty milliliters per minute per 1.73 meters square. 6.Subjects with cognitive impairment due to brain disease or mental illness. 7.Subjects with uncontrolled hypertension Systolic Blood Pressure greater than 140 mmHg or Diastolic Blood Pressure greater than 90 mmHg at the time of screening, or those whose hypertension is not controlled with stable medication for at least three months. 8.Subjects with uncontrolled diabetes (i.e., Random blood sugar greater than 200 milligram per deciliter at the time of screening or those whose diabetes is not controlled with stable medication for at least three months. 9.Subjects with thyroid-stimulating hormone levels outside the normal range. 10.Subjects with a history of unstable angina, myocardial infarction, transient ischemic attack, or coronary artery interventions, including coronary artery bypass surgery, inflammatory or rheumatologic disease, cerebrovascular incident, chronic hepatic disease, within six months prior to the consent date. 11.Subjects with a history of severe head trauma with loss of consciousness within three months prior to the consent date. 12.Subjects with a history of acute stroke within three months prior to the consent date. 13.Subjects with severe hearing or vision impairments that make efficacy evaluation impossible. 14.Pregnant or breastfeeding women, or those planning to become pregnant. 15.Subjects with hypersensitivity reactions to the IP ingredients. 16.Alcoholics (Inability to control drinking due to both physical and emotional dependence on alcohol, characterized by uncontrolled drinking and preoccupation with alcohol). 17.Subjects who are excessive smokers (greater than or equal to ten cigarettes per day). 18.Subjects who have participated in another clinical trial within the last three months. 19.Subjects deemed unsuitable for the study by the investigator s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognitive function as measured by the Mini Mental State Examination (MMSE) score and CANTAB (Cambridge Neuropsychological Test Automated Battery) assessments.Timepoint: MMSE: Baseline (Day 1), Week 6, Week 12, Week 18, and Week 24 CANTAB: Baseline (Day 1), Week 12, and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Sleep Quality Assessed using the Sleep Quality Scale (SQS) Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Change in Oxidative Stress Markers (Superoxide Dismutase [SOD], Catalase, Malondialdehyde [MDA]) Safety & Tolerability Assessed through adverse events (AEs), clinical laboratory tests, physical examination, & vital signsTimepoint: Change in Sleep Quality Time Points: Screening & Week 24 Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Time Points: Baseline, Week 12, & Week 24 Change in Oxidative Stress Markers (Superoxide Dismutase [SOD], Catalase, Malondialdehyde [MDA]) Time Points: Baseline, Week 12, & Week 24 Safety & Tolerability Time Points: All visits (Screening, Day 1, Weeks 6, 12, 18, & 24) | — |
Countries
India
Contacts
Public ContactMs Shashi Singh
Vimta Labs Limited
Outcome results
None listed