| CTRI Number |
CTRI/2025/10/096502 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Bioavailable Turmeric Extract on Healthy Aging |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Effects of Bioavailable Turmeric Extract on Biological Aging in Healthy
Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-02BCM0825H1-SYN08 version 01 dated 09 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,
Behind ISRO, Erumathala P.O.
Ernakulam KERALA 683112 India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,
Behind ISRO, Erumathala P.O.
Ernakulam KERALA 683112 India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Senior Scientist Clinical Research |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,
Behind ISRO, Erumathala P.O.
Ernakulam KERALA 683112 India |
| Phone |
09995215790 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt. Ltd. Desom Road, Aluva - 683102 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,
Behind ISRO, Erumathala P.O., Ernakulam, Kerala. Pin - 683112 |
| Type of Sponsor |
Other [Neutraceutical Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Giriraja K V |
Rajalakshmi Hospital and Research Center |
Room No.1, General Medicine OPD, Ground Floor, No.21/1, Lakshmipura Main Road,
Opp. Lakshmipura Lake, Vidyaranyapura Post Bangalore KARNATAKA |
09448039952
drgiriraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioavailable Turmeric extract |
One capsule in the morning containing 100 mg of Turmeric extract complex for 60 days |
| Intervention |
Bioavailable Turmeric extract |
One capsule in the morning containing 200 mg of Turmeric extract complex for 60 days |
| Comparator Agent |
Placebo |
One capsule in the morning for 60 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or female participants aged 50 years to 70 years
2. No clinically diagnosed chronic diseases
3. Normal blood pressure (SBP less than than 140 mmHg, DBP less than 90 mmHg)
4. Normal fasting blood glucose (less than or equal to 100 mg/dL)
5. Normal lipid profile (Total cholesterol less than 200 mg/dL, LDL less than 150 mg/dL, HDL greater than 40 mg/dL,
Triglycerides less than 150 mg/dL)
6. BMI 18.5 – 29.9 kg/m²
7. Willingness to provide informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
1. Clinically diagnosed conditions (hypertension, diabetes, cardiovascular disease, metabolic disorders)
2. Use of anti-inflammatory, antioxidant, or immune-modulating medications/supplements within 30 days before study enrolment
3. Major surgery or hospitalization in the past six months
4. Participation in another clinical trial within three months
5. Smoking or excessive alcohol consumption (greater than 2 standard drinks/day)
6. Any condition that may interfere with study compliance or data interpretation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in inflammatory and oxidative stress biomarkers |
Baseline, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in other metabolic and age-related biomarkers |
Baseline, Day 30, Day 60 |
| Mean change in scores of the assessment questionnaires |
Baseline, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| 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
|
We hypothesize that supplementation with bioavailable curcumin will improve markers of healthy ageing by reducing oxidative stress and systemic inflammation, supporting cognitive and physical performance,
and promoting overall physiological resilience in healthy adults.
The study will assess parameters that are mechanistically linked to ageing, including: Inflammatory markers to evaluate curcumin’s anti-inflammatory effect, Oxidative stress biomarkers to determine antioxidant capacity, Cognitive and physical function assessments to measure real-world implications of healthy ageing and Quality of life scores to assess subjective wellbeing. These parameters will help us comprehensively explore the healthy ageing potential of curcumin and provide translational evidence to support its use as a safe, nutraceutical intervention for longevity and improved life quality.
|