| CTRI Number |
CTRI/2018/03/012393 [Registered on: 07/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A pilot study to evaluate the safety and advantages of CurQfen on brain function in middle aged to elderly people. |
|
Scientific Title of Study
|
An open-label, single centre, pilot clinical study to evaluate the effect of CurQfen on brain function in Middle aged to Elderly population by Quantitative EEG analysis and cognitive assessment tests. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Aman Hospital and Research Centre Pvt Ltd
15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnakumar I M |
| Designation |
General Manager R and D |
| Affiliation |
Akay Flavours and Aromatics Private Limited |
| Address |
Research and Development Division ,1st Floor, Malaidamthuruthu
Ernakulam
KERALA
Ernakulam
KERALA
683561
India |
| Phone |
|
| Fax |
|
| Email |
Krishnakumar.IM@akay-group.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Flavours and Aromatics Private Limited ,Malaidamthuruthu P.O Ernakulam Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Akay Flavours and Aromatics Private Limited |
| Address |
Malaidamthuruthu P.O Ernakulam Kerala, India. |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Aman Khanna |
Aman Hospital and Research Centre |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital Vadodara Gujarat
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CurQfen |
500mg capsules 2 times in a Day |
| Comparator Agent |
Normal Cucumin |
500mg Capsules 2 times in a Day |
| Comparator Agent |
Placebo |
500mg capsules 2 times in a day with no active ingredient |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 35-65 Years ( Both Inclusive)
2) Male and Female Subjects
3) Subjects in general good health.
4) Subjects with a MMSE score between 25 – 30
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1) Subjects with a education qualification less than higher secondary level
2) Subjects who are not familiar with computer/internet use.
3) Subject with dementia/related memory loss illness
4) Subjects diagnosed with learning difficulty such as dyslexia or dyspraxia
5) Suffering from any form of clinically diagnosed disease, including:
o Major mental illness (current or previous episode with hospitalization)
o Chronic fatigue syndrome
o Liver disease
o Diabetes mellitus
o Heart disease or myocardial infarction
o underwent brain surgery
o who have a central nervous system illness
o neurological lesion
6) Subjects with a known allergy to herbal products
7) Subjects with abnormal biochemical or haematological values
8) Subjects with abnormal blood pressure
9) Pregnant or Lactating Women
10) Any condition that in Opinion of the Investigator, does not justify the Subjects’ participation in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Comparative changes EEG in basline and after administration of CurQfen
-Comparative changes in cognitive assessment test scores
|
Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Change in Brain Derived Neurotrophic factor (BDNF)
- safety of CurQfen |
Day 0, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2017 |
| Date of Study Completion (India) |
29/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Single Centre Open Label Clinical study. The main purpose of the study is to prove the efficacy of CurQfen on Brain Function. Helathy subjects are enrolled to participate in the study. Informed consent is obtained before undertaking any study related procedures. Subjects with a MMSE score greater or equal to 25 are enrolled in the study. The subjects visited their designated study site on following 4 different occasions: Screening Baseline : Day 0 Visit 3 : Day 15 Visist 4 : Day 30 Efficay and safety is established by comparing the end of study values with baseline values..
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