| CTRI Number |
CTRI/2024/10/075786 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A single Dose oral bioavailability study of investigational product containing Phosphatidylserine, in healthy, adult, human subjects under fasting conditions. |
|
Scientific Title of Study
|
A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Period, Two-Way
Crossover, Oral Bioavailability Study of Investigational Product Containing Phosphatidylserine, In Healthy,
Adult, Human Subjects Under Fasting Conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VCR-CSP-24/005 version1.0 date 03sept2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambanna Gowda |
| Designation |
Consultant Physician |
| Affiliation |
Unitree Healthcare and Diagnostics |
| Address |
Unitree Health Care and Diagnostics, 38/1 Church Road, Marappa Garden, J C Nagar.
Bangalore
KARNATAKA
560006
India |
| Phone |
9845270377 |
| Fax |
- |
| Email |
gowdaambanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambanna Gowda |
| Designation |
Consultant Physician |
| Affiliation |
Unitree Healthcare and Diagnostics |
| Address |
Unitree Health Care and Diagnostics, 38/1 Church Road, Marappa Garden, J C Nagar.
KARNATAKA
560006
India |
| Phone |
9845270377 |
| Fax |
- |
| Email |
gowdaambanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Dayananda |
| Designation |
Project Manager |
| Affiliation |
Vivatiq Clinical Research |
| Address |
Vivatiq Clinical Research, # 358/274, Srigandha Nagar Main Road,
Hegganahalli, Vishwaneedam Post, (near Peenya Industrial Area 2nd stage),
Bangalore
KARNATAKA
560079
India |
| Phone |
9980107723 |
| Fax |
- |
| Email |
vivatiqcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shankar Nutricon Private Limited. M-45, M-46, M-47, M-48, and M49 –A
ISEZ Phase- II (Misc. Zone)
Pithampur Dist. Dhar
Pin 454775 |
|
|
Primary Sponsor
|
| Name |
Shankar Nutricon Private Limited |
| Address |
M-45, M-46, M-47, M-48, and M49 –A
ISEZ Phase- II (Misc. Zone)
Pithampur Dist. Dhar
Pin- 454775
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Academy of Material Research |
Mahatma Gandhi University Innovation Foundation Building No. 572 Priyadarshini Hills Athirampuzha Kottayam Kerala India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambanna Gowda |
Unitree Health Care Diagnostics |
Ground floor , Consultation room, 38/1, Church Road, Marappa Garden, J C Nagar, Bengaluru
Bangalore
KARNATAKA |
9845270377
-
gowdaambanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive Health |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Actiserine - Phosphatidylserine Formulation (150 mg) |
a single dose will be administered orally, (as per randomization schedule) along with water, to the subjects in sitting posture - on Day 1 and Day 8(cross over) |
| Comparator Agent |
Conventional Phosphatidylserine 150mg |
a single dose will be administered orally, (as per randomization schedule) along with water, to the subjects in sitting posture on Day 1 and Day 8(cross over) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2 .
2. Subject agrees avoid Phosphatidylserine containing medications and dietary supplements from screening until last visit.
3. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
4. Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
5. Subjects generally healthy as documented at screening considered by the physician or principal/clinical investigator.
6. Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
|
|
| ExclusionCriteria |
| Details |
1. Evidence of allergy or known hypersensitivity to Phosphatidylserine or other related drugs or other related drugs.
2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
3. Any major illness in the last three months or any significant ongoing chronic medical illness.
4. Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
5. History of alcohol addiction or abuse.
6. Malabsorption syndrome that affects Phosphatidylserine metabolism.
7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than 100 per min ventricular rate.
8. Gastrointestinal bleeding in past three months.
9. Uncontrolled diabetes mellitus.
10. Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
11. Psychopathic disorder, lack of cooperation.
12. Chronic obstructive lung disease or active smoking - more than 2 cigarettes in the past 6 months.
13. Taking more than 150 mg Phosphatidylserine daily within 2 weeks to screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the oral bioavailability of investigational product contains 150 mg of Phosphatidylserine of Molecules BioLabs Private Limited, and the reference product in healthy, adult, human subjects under fasting conditions.
2. To monitor adverse event and to ensure safety of the subjects. |
At Screening and End of Study visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To monitor the adverse events and to ensure the safety of the subjects. |
before and after dosing of study product. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Phosphatidylserine is an amino acid derivative that is fat soluble and found in high amounts in the brain. It protects nerve cells in the brain and enables them to communicate with each other. The nutritional supplement phosphatidylserine promotes cognitive function and memory. The amount of natural phosphatidylserine in body decreases as getting old. Phosphatidylserine is a type of phospholipid. It exists in your brain cell membranes, or the part of cell that protects the inside of the cell from the outside environment. Phosphatidylserine is believed to play a role in mood regulation, restorative sleep, and cognitive functions, such as attention, focus, processing speed, and memory. Phosphatidylserine is part of the cell structure in the body. The body can make phosphatidylserine, but most of what it needs comes from foods. It can also be taken as a supplement.Phosphatidylserine is a phospholipid nutrient found in fish, green leafy vegetables, soybeans and rice, and is essential for the normal functioning of neuronal cell membranes and activates Protein kinase C (PKC) which has been shown to be involved in memory function. |