| CTRI Number |
CTRI/2019/05/019392 [Registered on: 28/05/2019] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial on eye health in healthy elderly volunteers. |
Scientific Title of Study
Modification(s)
|
A Prospective, Double Blind, Randomized, Placebo Controlled Interventional Study, to evaluate Safety and Efficacy of Centella Asiatica Extract tablets in Improving MPOD Levels in Elderly Volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RM/MPOD/2019 (Version 2 6th May 2019) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
Director |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
99/A, 8 Main, III Phase
Peenya Industrial Area, Bangalore-560058
Bangalore
KARNATAKA
98809 99297
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
Director |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
99/A, 8 Main, III Phase
Peenya Industrial Area, Bangalore-560058
Bangalore
KARNATAKA
98809 99297
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
Director |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
99/A, 8 Main, III Phase
Peenya Industrial Area, Bangalore-560058
Bangalore
KARNATAKA
98809 99297
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
ashok@radiantresearch.in |
|
|
Source of Monetary or Material Support
|
| GENENCELL CO., LTD
# 301, U Tower, 120, Heungdeokjungang-ro,
Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
|
|
|
Primary Sponsor
|
| Name |
GENENCELL CO LTD |
| Address |
# 301, U Tower, 120, Heungdeokjungang-ro,
Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Radiant Research Private Limited |
# 99/A, 8 Main, III Phase, Peenya Industrial Area,
Bangalore-560058, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thirumalesh MB |
Narayana Nethralaya |
Narayana Health City, NarayanHrudayalaya Campus 258/A Bommasandra, Hosur Rd, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA |
9845928933
thirumaleshmb@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 |
| Healthy Human Volunteers |
Eye health |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
CENTELLA ASIATICA 900 mg EXTRACT TABLETS |
Dose: 900 mg
Dosage: one tablet per day
Route: orally |
| Comparator Agent |
Placebo containing Maltodextrin |
Dose: 900 mg Tablet
Dosage: one Tablet per day
Route: Orally |
|
|
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
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Macular pigment optical density measurement |
Day 0,Day 60, Day 120 and Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety parameters like Vitals,Liver function tests, Haematology and 4. Renal Function Tests |
Day 0 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Mechanism to improve eye health by Centella asiatica (CA) has not been studied, therefore we performed this experiment for the first time. We investigated the effects of CAE50, asiaticoside and asiatic acid, which are active ingredients, on the inhibition of retinal cell injury in vitro..
the primary objective of this study is to evaluate the safety and efficacy of centella asiatica extract tablets in improving MPOD levels in elderly volunteers |