| CTRI Number |
CTRI/2024/12/078490 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial on Lutein and Zeaxanthin Supplementation on Eye Health in Elderly Adults |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax(R) 2004 (10mg and 20mg Lutein and Zeaxanthin) oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XANMAX 2004 / MPOD/2024 V No:1.0 Dated 24th October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Gopi Krishna G |
| Designation |
Principal investigator |
| Affiliation |
Narayana Nethralaya |
| Address |
121/C, Chord Rd, Near Iskcon Temple, 1st R Block, Ground floor Floor Department of ophthalmology Room no : 2
Rajajinagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560010
India |
| Phone |
9880643039 |
| Fax |
|
| Email |
drsantoshgk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Priya M K |
| Designation |
Sr.VP-Carotenoid Business |
| Affiliation |
Katra Phytochem (India) Private Limited |
| Address |
Plant No. 7, A-1, Attibele Industrial Area,Anekal Taluk, Bangalore
District Karnataka, India
Bangalore
KARNATAKA
9844593322
India |
| Phone |
9844593322 |
| Fax |
|
| Email |
priya@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Priya M K |
| Designation |
Sr.VP-Carotenoid Business |
| Affiliation |
Katra Phytochem (India) Private Limited |
| Address |
Plant No. 7, A-1, Attibele Industrial Area,Anekal Taluk, Bangalore
District Karnataka, India
Bangalore
KARNATAKA
9844593322
India |
| Phone |
9844593322 |
| Fax |
|
| Email |
priya@katraphyto.com |
|
|
Source of Monetary or Material Support
|
| Daehan Chemtech CO., LTD.
B-1208, 65, Gwacheon-daero 7-gil
Gwacheon-si, Gyeonggi-do 13840, South Korea
|
| Katra Phytochem (India) Private Limited
Plant No. 7, A-1, Attibele Industrial Area,
Anekal Taluk, Bangalore District – 562107, Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Katra Phytochem (India) Private Limited |
| Address |
Plant No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bangalore District – 562107, Karnataka, India |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Daehan Chemtech CO LTD |
B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do 13840, South Korea |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Gopi Krishna G |
Narayana Nethralaya |
121/C, Chord Rd, Near Iskcon Temple, 1st R Block, 1st Floor Room no : 2
Rajajinagar, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9880643039
drsantoshgk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Nethralaya Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose:300mg (Each capsule contains 0 mg of Lutein/ Zeaxanthin (5:1)
Dosage form: soft gel capsule
Route of administration: Oral
Frequency: One capsule orally 30 minutes after breakfast
Duration: 120 days |
| Intervention |
XanMax 2004 (Lutein/Zeaxanthin 10 mg in ratio of 5:1) |
Dose:300mg (Each capsule contains 10mg of Lutein/ Zeaxanthin (5:1)
Dosage form: soft gel capsule
Route of administration: Oral
Frequency: One capsule orally 30 minutes after breakfast
Duration: 120 days
|
| Intervention |
XanMax 2004 (Lutein/Zeaxanthin 20 mg in ratio of 5:1) |
Dose:300mg (Each capsule contains 20mg of Lutein/ Zeaxanthin (5:1)
Dosage form: soft gel capsule
Route of administration: Oral
Frequency: One capsule orally 30 minutes after breakfast
Duration: 120 days
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Volunteers of any sex, aged 45 to 65 years.
2. Volunteers with a body mass index (BMI) between 20 and 33 kg/m².
3. Volunteers with macular pigment optical density (MPOD) levels between 0.2 and 0.4.
4. Volunteers with no clinically significant ocular pathological conditions (minor and clinically insignificant accommodation issues of the eyes may be included).
5. Willing and able to adhere to the dietary regimen outlined in the study protocol.
6. Willing to attend regular follow-up visits as specified in the study protocol.
7. Capable of providing written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to herbal extracts, dietary supplements, or study related components.
2. Presence of clinically significant ocular pathologies, including but not limited to glaucoma, mature cataracts, or pan-retinal degenerations.
3. History or diagnosis of systemic diseases such as hypercholesterolemia, renal disorders, hepatic disorders, diabetes mellitus, or other debilitating conditions.
4. Current or recent treatment in the last three months with herbal or allopathic ocular medications.
5. Participation in any other clinical trial or receipt of an investigational drug within the last three months.
6. Any condition that, in the investigators judgment, would preclude safe participation in the study or compromise study results.
7. Pregnant or lactating women, women planning to conceive during the study period, or women less than six months postpartum.
8. Prior use of lutein, zeaxanthin, or other antioxidant replacement therapies within the six months preceding the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in MPOD levels |
Day 0, Day 60 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety Assessments (hematology, serum chemistry and urine analysis) |
Day 0 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| Date of Study Completion (India) |
14/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
Lutein and zeaxanthin are essential components of macular health, with significant evidence supporting their role in preventing and managing AMD, cataracts, and other retinal disorders. Their supplementation represents a promising strategy for enhancing visual function and mitigating age-related visual decline, particularly in populations with low dietary intake of carotenoids. The inclusion of lutein and zeaxanthin in clinical and public health strategies has the potential to address the growing burden of visual impairment and improve quality of life in diverse populations. Given the established benefits of lutein and zeaxanthin for eye health, this study aims to evaluate the comparative efficacy of XanMax® 2004 10 mg capsule (containing lutein and zeaxanthin in 5:1 ratio), XanMax® 2004 20 mg capsule (containing lutein and zeaxanthin in 5:1 ratio) and a matching placebo capsule in improving the macular pigment optical density (MPOD) in elderly volunteers. This randomized, double-blind, placebo-controlled, parallel study will provide valuable insights into the potential synergistic effects of these compounds in promoting ocular health and preventing age-related vision impairment. The present study is designed to confirm the efficacy and safety of lutein and zeaxanthin with the study title—“A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax® 2004 (10 mg and 20 mg lutein / zeaxanthin) oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers.†|