| CTRI Number |
CTRI/2025/07/091775 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to test if Pinorox® (Pine Bark Extract) capsules are safe and helpful for improving memory and thinking in older adults with age-related memory problems. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Pinorox® (Pine Bark Extract) Capsule (Group I: Test) Compared to Placebo Capsule (Group II: Reference) for Cognitive Impairment in subjects impaired by aging. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaji Paulose |
| Designation |
Sr. Program Manager |
| Affiliation |
Vimta Labs Limited |
| Address |
141 2 and 142, IDA, Phase 2 Cherlapally
Hyderabad 500051, Telangana, India.
Hyderabad
TELANGANA
500051
India |
| Phone |
9742242435 |
| Fax |
04027263657 |
| Email |
shaji.paulose@vimta.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh A Shah |
| Designation |
Head Clinical Trials |
| Affiliation |
Vimta Labs Limited |
| Address |
141 bar 2 and 142, IDA, Phase 2 Cherlapally
Hyderabad 500051, Telangana, India.
Hyderabad
TELANGANA
500051
India |
| Phone |
9004181455 |
| Fax |
04027263657 |
| Email |
kalpesh.shah@vimta.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Shashi Singh |
| Designation |
AGM R&D and Regulatory Affairs |
| Affiliation |
Ambe Phytoextracts Pvt Ltd |
| Address |
Corporate Address Sector 63, A 144 Noida,
Uttar Pradesh 201301, India.
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999577920 |
| Fax |
|
| Email |
shashi.singh@ambe-group.com |
|
|
Source of Monetary or Material Support
|
| Ambe Phytoextracts Pvt Limited,
Corporate Address: Sector 63, A – 144 Noida,
Uttar Pradesh 201301, India.
|
|
|
Primary Sponsor
|
| Name |
Ambe Phytoextracts Pvt Ltd |
| Address |
Sector 63, A 144 Noida, Uttar Pradesh 201301, India. |
| Type of Sponsor |
Other [Nutraceutical Industry - Global] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshith C S |
BGS Global Institute of Medical Sciences |
BGS Global Institute of Medical Sciences No.67 BGS Health and education city, uttarahalli road, kengeri, Bangalore - 560060
Bangalore
KARNATAKA |
9972539315
drharshithcs.research@gmail.com |
| Dr Vidya G S |
Rajarajeswari Medical College and Hospital |
Rajarajeswari Medical College and Hospital, 202, kambipura, Mysore road, Bangalore, Karnatak
Bangalore
KARNATAKA |
9611011330
drvidyags.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BGS Global Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Raja Rajeswari Medical College and Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I :Pinorox® (Pine Bark Extract)
100 mg Capsule (Test Product)
|
100mg, Once a day, Oral for 6 months |
| Comparator Agent |
Group II Placebo Capsule ( Comparator agent) |
100mg, Once a day, Oral for 6 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cognitive function as measured by the Mini Mental State Examination (MMSE) score and CANTAB (Cambridge Neuropsychological Test Automated Battery) assessments. |
MMSE: Baseline (Day 1), Week 6, Week 12, Week 18, and Week 24
CANTAB: Baseline (Day 1), Week 12, and Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 signs |
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) |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
A randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study designed to evaluate the efficacy and safety of Pinorox® (Pine Bark Extract) 100 mg capsules compared to placebo in subjects with age-related cognitive impairment.The study will be conducted over approximately 180 days at a minimum of two sites in India. It includes six scheduled visits during which participants will undergo periodic assessments to evaluate cognitive function using tools such as MSME, CANTAB, and relevant biomarkers.Safety will be monitored through routine laboratory tests and the documentation of any adverse events. |