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CTRI Number  CTRI/2016/10/007413 [Registered on: 27/10/2016] Trial Registered Retrospectively
Last Modified On: 08/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A healthy volunteers study on elderly population to understand if thee is any improvement in MPOD levels 
Scientific Title of Study   A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax® 2002 oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers 
Trial Acronym  MPOD 
Secondary IDs if Any  
Secondary ID  Identifier 
MPOD/XANMAX/2016, Version 01 Date 12Apr2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naveen Kumar Naik 
Designation  Consultant Vitreo-retina 
Affiliation  Narayana Nethralaya 
Address  121/C, Chord Road, 1st ‘R’ Block, Rajaji Nagar, Bengaluru.

Bangalore
KARNATAKA
560010
India 
Phone    
Fax    
Email  naveen_24kumar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Bose R C 
Designation  Sr Manager, Research Technical 
Affiliation  Kathra Phytochem (India) Pvt Ltd 
Address  Katra Phytochem (India) Pvt Ltd, No. 1134, 1st Floor, 100 Feet Road, Indiranagar, HAL 2nd Stage, Bengaluru

Bangalore
KARNATAKA
560008
India 
Phone    
Fax    
Email  bose@keralaayurveda.biz  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical research Services Pvt Ltd 
Address  Syncretic Clinical research Services Pvt Ltd, No.4, 5th Cross, 11th Main Rd, Vasanthnagar, Bangalore

Bangalore
KARNATAKA
560052
India 
Phone    
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
Katra Phytochem India Private Limited 
 
Primary Sponsor  
Name  Katra Phytochem India Private Limited 
Address  #1134,1st Floor, 100 ft Road, HAL 2nd Stage, Indiranagar, Bangalore - 560008, Karnataka, India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naveen Kumar Naik  Narayana Nethralaya  121/C, Chord Road, 1st ‘R’ Block, Rajaji Nagar, 560010
Bangalore
KARNATAKA 		 9902455992

naveen_24kumar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Sunflower oil Dose - 20 mg Frequency - one soft gel capsule once daily 30 minutes after meals Duration - 6months Route of Administration - Oral  
Intervention  XanMax® 2002   Lutein and Trans-Zeaxanthin and sunflower oil Dose - 20 mg Frequency - one soft gel capsule once daily 30 minutes after meals Duration - 6months Route of Administration - oral 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a.Volunteers of either sex, between 45 to 65 years of age.
b.Volunteers with MPOD level between 0.2 – 0.4
c.Volunteers having no clinically significant ocular pathological condition, but clinically non-significant problem with accommodation of the eye can be included.
d.Able to abide the dietary regime mentioned in the protocol
e.Willing to come for regular follow –up visits.
f.Able to give written informed consent.
 
 
ExclusionCriteria 
Details  a.Known history of hypersensitivity to herbal extracts or dietary supplements.
b.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc. will be excluded.
c.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
d.On-going treatment with herbals or allopathic ocular drugs.
e.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
f.Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Macular pigment density measurement  Day 0, 60,120 and 180 
 
Secondary Outcome  
Outcome  TimePoints 
Macular pigment ocular density  Day 0, 60, 120 and 180 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/08/2016 
Date of Study Completion (India) 11/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Elderly volunteers whose MPOD values are between 0.2 and 0.4 will be enrolled into the study after obtaining Institutional Ethics Committee approved Informed Consent, in writing. All 60 subjects will receive either placebo or active product in the ratio of 1:1 for a period of 180 days (6 months), as one soft gel capsule once daily, to be taken 30 min after meals. Their respective MPOD values on Day 0, 60, 120 and 180 will be measured and analyzed. Subject’s daily intake of vitamin A and carotenoid, if any, will be captured in patient diaries. At the end of 3 and 6 months of treatment, interim analysis will be done in addition to complete data analysis towards end of the study (after 15 day follow-up).

 
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