| CTRI Number |
CTRI/2024/09/074434 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Pharmacokinetic Study Comparing Cinnamon Bark Extract 15 Mg Cinnamaldehyde Capsule |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Pharmacokinetic Study Comparing Cinnamon Bark Extract W Capsules 15 mg cinnamaldehyde capsule Manufactured by Nutriventia Limited With Cinnamon Bark Extract Capsules 30 mg cinnamaldehyde capsule manufactured by Synthite Industries Private Limited In Healthy Adult Human Male Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0013-24-CINN Version No 01 Dated 10 Sep 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and research private limited |
| Address |
Clinical Trial Division
Ground Floor
Door No 29 A Krishna Maduravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and research private limited |
| Address |
Clinical Trial Division
Ground Floor
Door No 29 A Krishna Maduravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life science and research private limited |
| Address |
Clinical Trial Division
Ground Floor
Door No 29 A Krishna Maduravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Nutriventia Limited
7th Floor Unit
703 704 Solaris one Premises Housing Society NS Phadke Road
Andheri E
Mumbai 400069
Maharashtra India
|
|
Primary Sponsor
Modification(s)
|
| Name |
Nutriventia Limited |
| Address |
7th Floor Unit
703 704 Solaris one Premises Housing Society
NS Phadke Road
Andheri E
Mumbai 400069
Maharashtra India
|
| Type of Sponsor |
Other [Nutraceutical Industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Maduravanam
Vellakinar Pirivu
thydiyalur
Coimbatore 641029
|
|
|
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 Trial Division
Ground Floor
No 29 A Krishna Maduravanam
Vellakinar Pirivu
Thudiyalur
Coimbatore-641029
Coimbatore
TAMIL NADU |
8220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting conditions |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Cinnamon Bark Extract Capsules |
1 capsule of Cinnamon Bark Extract 30mg per capsule will be administered as single dose as oral administration in each period 11 days duration |
| Intervention |
Cinnamon Bark Extract W Capsules |
2 capsules of Cinnamaldehyde each 15 mg per capsule will be administered as single dose as oral administration in each period 11 days duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Normal healthy adult human male 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 willing to follow diets free of cinnamon and any spice mixtures containing cinnamon starting at least 7 days before period I check in till end of period II including entire study period
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 are 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 not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume Ovo lacto vegetarian diet
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to cinnamaldehyde or its inactive ingredients
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 on going chronic medical illness
Renal or liver impairment
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or xanthine containing 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 14 days prior to study check in and throughout the study
Subjects who have taken any unusual diet for whatever reason 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 the start of the study check in
Use of hormone replacement therapy for a period of 06 months prior to dosing
|
|
|
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 Oral Pharmacokinetic of Cinnamon Bark Extract W Capsules 15 mg cinnamaldehyde per capsule Manufactured by Nutriventia Limited with Cinnamon Bark Extract Capsules 30 mg cinnamaldehyde capsule manufactured by Synthite Industries Private Limited in Healthy Adult Human Male Subjects Under Fasting Conditions |
22 samples
–12 00 hrs –02 00 hrs 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 01 00 hrs 01 25 hrs 01 50 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 36 00 hrs
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To monitor the safety & tolerability of test product comparing with the reference product in Healthy Adult Human Male Subjects Under Fasting Conditions |
22 Samples
–12 00 hrs –02 00 hrs 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 01 00 hrs 01 25 hrs 01 50 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 36 00 hrs
|
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
15/11/2024 |
| 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)
Modification(s)
|
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
Modification(s)
|
At least 12 healthy, adult, human male subjects will be recruited to evaluate the Pharmacokinetic of Test product with the Reference product In each period, subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 36.00 hours post dose. A washout period of at least 07 days will be maintained between each dosing period. Monitoring for adverse events will be done throughout the study period in the clinical phase. |