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CTRI Number  CTRI/2025/01/079661 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   An Single Dose, Two-Treatment study Of Actif Plus (500 Mg), Actif (500Mg) Capsules in Healthy, adult, human male subjects. 
Scientific Title of Study   An Open-Label, Balanced, Randomized, Single Dose, Two-Treatment, Two-Period, Two-Sequence, Two-Way Crossover Study Of Relative Bioavailability Of (T1) Actif Plus (500 Mg), (T2) Actif (500Mg) Capsules Containing Curcuminoids, In Healthy, Adult, Human Male Subjects Under Fed Conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
VCR-CSP-24/009 Version No.: 1.0 Date 14 Nov 2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  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 Health Care Diagnostics 
Address  38/1, Church Road, Marappa Garden, J C Nagar

Bangalore
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  358/274, Srigandha Nagar Main Road, Hegganahalli, Vishwaneedam Post, (near Peenya Industrial Area 2nd stage)
-
Bangalore
KARNATAKA
560079
India 
Phone  09980107723  
Fax  -  
Email  vivatiqcr@gmail.com  
 
Source of Monetary or Material Support  
Molecules BioLabs Pvt Ltd, Kinfra, Koratty, Kerala, India - 680309 
 
Primary Sponsor  
Name  Bernd-Michael Loffler Institute for mitochondrial medicine 
Address  Bernd-Michael Loffler Institute for mitochondrial medicine Pfalzburger str 43-44 10177 Berlin  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
MOLECULES BIOLABS PRIVATE LIMITED   Kinfra, Koratty, Kerala - 680309 
 
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   38/1, Church Road, Marappa Garden, J C Nagar
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  antioxidant and anti-inflammatory. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuminoids Formulation I - ACTIF PLUS (500 mg capsule containing Not Less Than 250 mg of curcuminoids/ capsule)  Two capsules (500mg) to be taken only once at randomization visit. 
Comparator Agent  Curcuminoids Formulation II- ACTIF (500 mg capsules which contains not less than 250 mg of curcuminoids)  Two capsules (500mg) to be taken only once at randomization visit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Normal, healthy, adult, Human Male 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 to avoid high activity physical exercise 72.00 hours prior to last visit
3. Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 21 days of check-in.
4. Subjects generally healthy considered by the physician or principal/clinical investigator to clinically, as documented by 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.
5. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
6. Willing to consume standard breakfast.
7. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
8. No consumption of Curcumin in a washout period of 14 days before the pharmacokinetic study
 
 
ExclusionCriteria 
Details  1. Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
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 haemopoeitic, 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 Curcumin metabolism.
7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with mor than 100 per min ventricular rate.
8. Gastrointestinal bleeding in the past three months.
9. Uncontrolled diabetes mellitus.
10. Active psychiatric disorder, intention for suicide, 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 500 mg curcumin daily within 2 weeks to screening.
14. Consumption of caffeine and /or Xanthine containing products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 48.00 hours prior to dosing and throughout the entire study
15. Consumption of alcohol and its products, grapefruit and/or its juice and poppy containing foods for at least 72.00 hours prior to dosing and throughout the study.
16. Subjects should not take any over the counter medicinal products, herbal medications within 07 days prior to study check in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study.
17. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.
18. An unusual or abnormal diet within 48.00 hours prior to study dosing of each period, for whatever reason e.g., because of fasting due to religious reasons.
19. Subject who had participated in any other study within the 90 days of check-in.
20. History of difficulty in swallowing.
21. History of difficulty in accessibility of veins.
22. Positive results for alcohol breath test prior to check-in of each period
23. Any blood donation / excess blood loss within 90 days of check-in.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the relative bioavailability of (T1) Actif plus (500 mg capsule containing NLT 250 mg of curcuminoids/ capsule) of Institute for Mitochondrial Medicine, and (T2) Actif (500 mg capsules which contains 250 mg of curcuminoids) of Institute for Mitochondrial Medicine in healthy, adult, male subjects under fed conditions.   Enrollment day. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor adverse events and to ensure the safety of the subjects.  Screening visit and End of study. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   07/02/2025 
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="3"
Days="0" 
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   Curcumin is a natural compound found in turmeric, a spice commonly used in Indian cuisine and traditional medicine. It is known for its bright yellow colour and potential health benefits. Curcumin has powerful antioxidant and anti-inflammatory properties, which may help reduce inflammation in the body and protect against chronic diseases. Curcumin is a naturally occurring phytocompound extracted from the turmeric rhizome Curcuma longa, a member of the ginger (Zingiberaceae) family. However, its low bioavailability due to poor absorption and rapid elimination limits its efficacy. ACTIF Plus, a novel curcuminoids formulation using innovative technology, shows higher bioavailability, shelf life and promising therapeutic applications. So, the bioavailable form of Curcuminoids helps to overcome the degradation of Curcumin due to high reactivity. It also improves the absorption into intestine by the controlled release of Curcumin. 
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