| CTRI Number |
CTRI/2020/09/027802 [Registered on: 14/09/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| 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 clinical study to evaluate the efficacy of NEUROCAF in reducing the risk of developing Parkinson’s disease. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of NEUROCAF in healthy elderly subjects at risk of developing Parkinson’s disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Manwani |
| Designation |
Principal Investigator |
| Affiliation |
Gujarat Kidney and Super Speciality Hospital |
| Address |
Department of General Medicine
1st Floor, Nr Jetalpur Bridge, Jetalpur Rd, Vadodara
Vadodara
GUJARAT
390020
India |
| Phone |
|
| Fax |
|
| Email |
karishma.manwaninm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research,#9, 1st Floor, Mythri Legacy, chelekere main road, Kalyan Nagar,
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research,#9, 1st Floor, Mythri Legacy, chelekere main road, Kalyan Nagar,
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar
Bengaluru, Karnataka - 560078,India
|
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078 |
| 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 Karishma Manwani |
Gujarat Kidney and Super Specialty Hospital |
Department of General Medicine 1st Floor, Nr Jetalpur Bridge, Jetalpur Rd, Vadodara
Vadodara
GUJARAT |
992529932
karishma.manwaninm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal Hematological and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEUROCAF |
Oral administration of single dose of NEUROCAF at the morning for 84 days |
| Comparator Agent |
Placebo |
Oral administration of single dose of placebo at the morning for 84 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Should not be an any medication for cognition and other neurological disorders
2. Post-menopausal women
3. Must be willing and able to give informed consent and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of Neurogenerative disorder, including Parkinson’s disorder,Psychiatric disorders ,Uncontrolled / serious medical illness including diabetes, liver disease, hypertension,Cardiac Disease/Neurological Problems,Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes),Gastrointestinal tract bleeding / peptic ulcer disease
2. Subjects having symptoms of viral infection, including COVID-19 infection
3. Subjects who may be allergic to any of the natural constituents of the Investigational Product.
4. Known HIV or Hepatitis B positive or any other immuno-compromised state
5. Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
6. Subjects visually or mentally handicapped or having difficulty to communicate
7. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing 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 |
| Changes in Bio markers of Parkinsons Disease |
Day 0, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in geriatric parameters
|
Day 0, Day 42, Day 84 |
| Safety of NEUROCAF |
Day 0, Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/09/2020 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects aged 55-65 years with and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized in 50:50 ratio into 2 treatment arms to receive NEUROCAF or placebo capsules for a period of 12 weeks.The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments .Cerebrospinal fluid (CSF) will be collected by lumbar puncture for the bio marker analysis Post blood sample collection, the subjects will undergo various assessments to evaluate their physical performance. Fatigue levels of subjects will be also assessed . The subjects will visit their designated study site on 3 different occasions during the 12 - week study.
|