| CTRI Number |
CTRI/2026/02/103386 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Open Label Single Dose Study To Evaluate Creneuros CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Ascending Dose Study To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid EPA and Calcium L 5 Methyltetrahydrofolate L 5 MTHF Following Oral Administration Of Different Dose Levels of Creneuros CNS Fish Oil Plus Softgels Supplied By Sichuan Credit Pharmaceutical Co Ltd China in Healthy Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0145-25-CREN Version No: 01 Date: 21 Jan 26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Sichuan Credit Pharmaceutical Co Ltd
Shunjiang Section of Wuhou Avenue
Wuhou District Chengdu City
Sichuan Province China 610045 |
|
|
Primary Sponsor
|
| Name |
Sichuan Credit Pharmaceutical Co Ltd |
| Address |
Shunjiang Section of Wuhou Avenue
Wuhou District Chengdu City
Sichuan Province China 610045 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu 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 Pradeep T |
Spinos Life science and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committe ECR/84/lndt/TN/2013/RR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CreNeuroS CNS Fish Oil Plus Softgels |
A Single oral dose of CreNeuroS CNS Fish Oil Plus Softgels will be administered in each period Total Duration of the study is 40 Days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
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 system and vital sign assessments
Generally healthy as documented by 12-lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments
Willing to consume ovo lacto vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period
If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Eicosapentaenoic Acid EPA and Calcium L-5-Methyltetrahydrofolate L 5 MTHF or its inactive ingredients.
Evidence of allergy to fish shellfish
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and caffeine-containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
Subjects who have taken an unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period
Positive results for alcohol test prior to check-in of each period
Any blood donation / excess blood loss within 90 days of check-in
Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in
Use of hormone replacement therapy for a Period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females likely to become pregnant during conduction of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Pharmacokinetic profile of single ascending doses of Eicosapentaenoic Acid EPA and Calcium L 5 Methyltetrahydrofolate L 5 MTHF after administration of CreNeuroS CNS Fish Oil Plus Softgels in healthy subjects under fasting condition
To demonstrate dose linearity of Eicosapentaenoic Acid EPA and Calcium L 5 Methyltetrahydrofolate L 5 MTHF following single dose administration different doses of CreNeuroS CNS Fish Oil Plus Softgels in healthy subjects under fasting condition |
32 Time points
-24.00 Hrs -12.00 Hrs -01.00 Hrs -00.50 Hrs 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 06.50 Hrs 07.00 Hrs 07.50 Hrs 08.00 Hrs 08.50 Hrs 09.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 120.00 Hrs 168.00 Hrs 240.00 Hrs 312.00 Hrs 384.00 Hrs 432.00 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of single ascending doses different doses of CreNeuroS CNS Fish Oil Plus Softgels in healthy subjects under fasting condition |
32 Time points
-24.00 Hrs -12.00 Hrs -01.00 Hrs -00.50 Hrs 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 06.50 Hrs 07.00 Hrs 07.50 Hrs 08.00 Hrs 08.50 Hrs 09.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 120.00 Hrs 168.00 Hrs 240.00 Hrs 312.00 Hrs 384.00 Hrs 432.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
04/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
At least 32 number of healthy, human subjects will be recruited to evaluate the Pharmacokinetic dose linearity in healthy subjects Note A total of 32 subjects 8 subjects in each groups will be enrolled in this study As per the discretion of the Investigator, a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 08 subjects in each cohorts during the study period In study period each group subjects will be housed in the clinical facility for at least -60.00 hours pre-dose to 72.00 hours post dose Dosing will be done individually for each cohort groups Cohort 01 Cohort 02 Cohort 03 Cohort 04 The subsequent group’s check in will be at the check out day of the previous group In study period after an overnight fasting of at least 08.00 hours in the morning a single oral dose of the test product T will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature to the subjects sitting in upright posture under the supervision of the investigator or medical officer and/or trained study personnel including the quality assurance auditors or monitors |