| CTRI Number |
CTRI/2019/12/022514 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate the Efficacy and Safety of vitamin NMN in Middle Aged and Older Adults for Anti-aging and Work-Out Enhancer |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults |
| Trial Acronym |
EFFE-CT-01 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Avhad |
| Designation |
Principal Investigator |
| Affiliation |
Swasthya Integrative Clinic |
| Address |
Swasthya Integrative Clinic, Off. No.5; Bramha Chambers, Near Janata Bank, Tilak Road,Sadashiv Peth,Pune
Off. No.5; Bramha Chambers, Near Janata Bank, Tilak Road,Sadashiv Peth,Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
08830446524 |
| Fax |
|
| Email |
avhadganesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Avhad |
| Designation |
Principal Investigator |
| Affiliation |
Swasthya Integrative Clinic |
| Address |
Swasthya Integrative Clinic, Off. No.5; Bramha Chambers, Near Janata Bank, Tilak Road,Sadashiv Peth,Pune
Off. No.5; Bramha Chambers, Near Janata Bank, Tilak Road,Sadashiv Peth,Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
08830446524 |
| Fax |
|
| Email |
avhadganesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sohal Pendse |
| Designation |
Operational Head |
| Affiliation |
ProRelix Services LLP |
| Address |
102 A/B, 1st Floor, Park Plaza, Near State Bank Colony, Karve Nagar, Pune .
102 A/B, 1st Floor, Park Plaza, Near State Bank Colony, Karve Nagar, Pune 411052.
Pune
MAHARASHTRA
411052
India |
| Phone |
9890096725 |
| Fax |
|
| Email |
s.pendse@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Effepharm (Shanghai) Co., Ltd , Room 1103, Lane 800, Meijiabang Rd, Shanghai 201620, China |
|
|
Primary Sponsor
|
| Name |
Effepharm Shanghai Co Ltd |
| Address |
Room 1103, Lane 800, Meijiabang Rd, Shanghai 201620, China |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamalakar Gajare |
Nirmaya Hospital |
Nirmaya Hospital,Survey no.88,Muhammadwadi road Pune,41160
Pune
MAHARASHTRA |
9822071732
drgajarekv@gmail.com |
| Dr Ganesh Avhad |
Swasthya clinic & Research centre |
5 Bramha Chambers, Near Janata Bank, 2010 Sadashiv Peth, Tilak Road, Pune 411030
Pune
MAHARASHTRA |
08830446524
avhadganesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anti-Aging and Work-Out Enhancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo capsules |
| Intervention |
Uthever (NMN supplement) |
route: Oral, Frequency: 2 capsules once a day, duration: 60 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male/females of 40 to 65 years of age
2. Body Mass Index (BMI) between 18.5 and 35 kg/m2
3. Able to provide written Informed Consent
4. Able to follow verbal and written study directions
5. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
6. Able to maintain consistent diet and lifestyle habits throughout the study
7. Male and female subjects must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study
8. Willing to consume assigned dietary supplements for 2 months
|
|
| ExclusionCriteria |
| Details |
1. Participants on current use of prescription or over-the-counter nicotinic acid
2. Use of statin drugs
3. Having used any tobacco product or used a recreational drug in the past 6 months
4. Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
5. Documented presence of atherosclerotic disease and/or cardiopulmonary disease
6. History of drug or alcohol abuse
7. History of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participant’s ability to comply with study requirements
8. Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start
9. Participating in or planning to begin a weight loss diet during the study period
10. Chronic use of over-the-counter medication which would interfere with study endpoints
11. Lifestyle or schedule incompatible with the study protocol
12. Known hypersensitivity to the drug components used during the study
13. Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding
14. Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
15. Currently, or within the past 30 days, enrolled in a different clinical investigation
16. Inability to provide a venous blood sample
17. Unable or unwilling to provide written informed consent for participation in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism |
To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the safety and tolerability of the formulation |
Visit 1, visit 2, visit 3, visit 4 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2019 |
| Date of Study Completion (India) |
15/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
| Sixty-six healthy male or female middle aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, Uthever (NMN supplement) or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either Uthever (NMN supplement) or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events. | |