| CTRI Number |
CTRI/2024/08/072478 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| 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 study to evaluate how well OxyjunTM improves Heart function as well as Work performance in Individuals with Metabolic health issues. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy of OxyjunTM on Cardiac Pumping Capacity as well as Work Productivity in Individuals with Metabolic Risk |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EB/240301/OXY/CPC, Version No. 1.0, Date: June 12, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director - Clinical Development and Strategy |
| Affiliation |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118,Morya House, Off New Link Road, Andheri (West),Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7738373850 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director - Clinical Development and Strategy |
| Affiliation |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118,Morya House, Off New Link Road, Andheri (West),Mumbai, Maharashtra, India.
MAHARASHTRA
400053
India |
| Phone |
7738373850 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Raote |
| Designation |
Manager - Clinical Operations |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118,Morya House, Off New Link Road, Andheri (West),Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7738373850 |
| Fax |
|
| Email |
sonal.raote@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd.
118-B, Morya House, off New Link Road, Andheri West
Mumbai – 400053, Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd. |
| Address |
118-B, Morya House, off New Link Road, Andheri West
Mumbai – 400053, Maharashtra, India
|
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhakar Singh |
Janta hospital & Maternity Centre |
Department of Medicine, Amra- Akhri Road, Bypass, Chunar Road, Varanasi, Uttar Pradesh 221011.
Varanasi
UTTAR PRADESH |
9235310199
sudhakarsinghvns26@gmail.com |
| Dr Devesh Rajani |
Medical Care Centre and Hospital |
Department of Medicine, Laxmi Complex, Kanpur-Lucknow Road, Ram Nagar, Alambagh, Lucknow, Uttar Pradesh - 226005
Lucknow
UTTAR PRADESH |
9415888888
deveshrajani@gmail.com |
| Dr Manoj Gerela |
Sigma Hospital |
Department of Medicine, Shanker Smruti building, MG Road, Mulund (W), Mumbai, Maharashtra - 400080
Mumbai
MAHARASHTRA |
9820565229
drmanoj@yahoo.com |
| Dr Avirath Acchammachary |
Silver Birch Multispecialty Hospital |
Department of Medicine, Plot No. 1 to 4, Near Sawtamali Mandir, Narhe – Dhayari Road, Pune
Pune
MAHARASHTRA |
9503607631
acchammacharyavirath@gmail.com |
| Dr Prashant Walke |
Swara Hospital |
Department of Medicine, Apollo Shopping Centre, Agashi Road, Gaothan, Virar West - 401303
Thane
MAHARASHTRA |
9860844434
prashantwalke18@gmail.com |
| Dr Ajit Kumar Jadhav |
Umarji Mother & Child Care Hospital |
Department of Cardiology, Survey No 13, beside Aditya Shagun Comfort zone, Balewadi Phata, Baner, Pune - 411045
Pune
MAHARASHTRA |
9028898494
ajit92698@gmail.com |
| Dr Ashutosh Singh |
Upendra Medicare Hospital |
Department of Medicine, S4/50, Mahaveer Mandir, Chauraha, Ardali Bazar Rd, Varanasi, Uttar Pradesh - 221001.
Varanasi
UTTAR PRADESH |
9085930945
ashugmc1@gmail.com |
| Dr Sachin Hundekari |
Vedant Multispeciality Hospital |
Department of Medicine, GP Block 83, Opp. Rotary Club, MIDC, Sambhajinagar, Chinchwad, Pune - 411019
Pune
MAHARASHTRA |
9960188184
drsachinhundekari.vedant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Submittted/Under Review |
| IEC-Vedant Multispeciality Hospital |
Approved |
| Institutional Ethics Committee Medical Care Centre and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Submittted/Under Review |
| Janta Hospital Ethics Committee |
Submittted/Under Review |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OxyjunTM |
One capsule daily to be taken after breakfast for 56 days |
| Comparator Agent |
Placebo |
One capsule daily to be taken after breakfast for 56 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals of either sex, aged more than equal to 45 to less than equal to 70 years at the time of screening with BMI more than equal to 25 kg/metre square to less than equal to 34.9 kg/metre square.
2.Individuals with normal to high blood pressure (BP) [systolic BP more than equal to 120 mmHg and less than equal to 159 mmHg and/or diastolic BP more than equal to 80 mmHg and less than equal to 89 mmHg].
3.Individuals with waist circumference more than equal to 40 inches for men or 35 inches for women.
4.Individuals with normal to mildly deranged ‘Left ventricular ejection’ as per American College of Cardiology: LVEF more than equal to 45% and less than equal to 55%.
5. Fasting glucose level of more than equal to 110 mg/dL and less than equal to 160 mg/dL (without medication or with maximum 500 mg of daily dose of Metformin).
6.Individuals with Aspartate aminotransaminase (AST) and Alanine transaminase (ALT) within 2 times upper normal limit (ULN).
7.Individuals with 1.5 x Upper Limit of Normal of Creatinine.
8.Individuals having following values of haemoglobin:
a) Female - more than equal to 11 mg/dl.
b) Male - more than equal to 12 mg/dl.
9. Individuals with thyroid stimulating hormone (TSH) levels between the 0.27 IU/ml and 5 IU/ml both values included.
10. Individuals who demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
11. Willing to abstain from caffeine for 12 hours prior to study visit.
12. Willing to abstain from alcohol and related products consumption for 48 hours prior to study visits.
13. Must be literate, having the ability to understand, complete the study-based questionnaires, requirements and sign a written informed consent form, which must be completed prior to study specific requirements being performed. |
|
| ExclusionCriteria |
| Details |
1. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgement of the investigator, would interfere with the individuals ability to provide informed consent, comply with the study protocol, or put the individual at undue risk.
2. Using Omega fish oil supplements, anticonvulsants, Coenzyme Q10, Vitamin K2, proton pump inhibitors, loop diuretics, anticoagulants, barbiturates, anti-epileptic medications and any herbal supplements (e.g. flax seeds, chia seeds).
3. Chronic use of anti-inflammatory medications (more than equal to 5 tablets/20 days in last 3 months).
4. Individuals having a history of smoking or currently smoking and also using any form of smokeless tobacco.
5. High-risk drinking as defined by consumption of 4 or more drinks of alcohol containing beverages on any day or 10 or more drinks of alcohol containing beverages per week for women and 5 or more drinks of alcohol containing beverages on any day or 14 or more drinks of alcohol containing beverages per week for men.
6. Individuals unable to walk.
7. Individuals with a history of chronic caffeine use with more than 3 cups of caffeinated beverage/ day.
8. Individuals who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put him/her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
9. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
10. Females undergoing hormone replacement treatments.
11. Peri- or post-menopausal females having less then equal to 1 year of irregular or complete absence of menstrual cycle.
12. Those unwilling to abstain from other dietary supplements or medication (e.g. Hepatoprotective agents and complementary and alternative medicine).
13. Have participated in a study of an investigational product 90 days prior to the screening.
14. Individuals with known or suspected hypersensitivity or intolerance to Investigational product.
15. Individuals who are unable to comply with study requirements.
16. Individuals with history of autoimmune disorders.
17. Individuals with history of immunocompromised status.
18. Any clinical signs or symptoms that in the opinion of investigator, can jeopardize the outcome of the study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF). |
Screening, Day 28, Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac pumping capacity as evaluated by the ventricular stroke volume and cardiac output. |
Screening, Day 28, and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Responder to the product as assessed by the number of the participant having LVEF more than equal to 5 units increase. |
Screening, Day 28, and Day 56 |
| To evaluate the effect of 8-week oral consumption of OxyjunTM on Work Productivity as assessed by the Work Productivity and Activity Impairment Questionnaire |
Day 0, Day 28 and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac risk as assessed by the NT-Pro BNP |
Day 0 and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Physical activity as assessed by IPAQ questionnaire. |
Day 0, Day 28 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
17/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is a randomized,
placebo-controlled, parallel-group study. 90 individuals will
be screened, and considering a screening failure rate of 30%, not more than
(NMT) 64 individuals will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique
randomization code. Each group will have at least 50 evaluable individuals after
accounting for a dropout/withdrawal rate of 20%. The intervention duration for
all the study participants is 56 days. |