| CTRI Number |
CTRI/2024/01/061726 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| 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 Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals. |
|
Scientific Title of Study
|
A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EB/231101/DI/VMF, Version 1.0, Date: Dec 13, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai,
Maharashtra, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai,
Maharashtra, India.
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Mote |
| Designation |
Project Lead - Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai,
Maharashtra, India.
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shubhangi.m@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd, B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053. |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053 |
| Type of Sponsor |
Contract research organization |
|
|
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 Sunira Khare |
Dr. Khares Clinic |
118 - B wing, Morya
house, New link road,
Andheri west
Mumbai
MAHARASHTRA |
9664056580
sunira.khare@gmail.com |
| Dr Preeti Bawaskar |
Dr. Preeti Bawaskars Clinic |
102, Ace business
Center Gokulnagar
Thane west
Thane
MAHARASHTRA |
9146680080
preeti.bawaskar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Altezza Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ageing |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carica papaya leaves extract |
1 capsule twice a day (Before Breakfast and dinner) for 90 days |
| Intervention |
Dolichos biflorus (Horsegram) seed extract |
1 capsule twice a day (Before Breakfast and dinner) for 90 days |
| Comparator Agent |
Placebo (MCC) |
1 capsule twice a day (Before Breakfast and dinner) for 90 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Physically active males and females aged more than or equal to 40 and less than or equal to 60 years.
2. Individuals with BMI more than or equal to 24.5 and less than equal to 34.9 kg per metre square.
3. Individuals with Fatigue Symptom Severity Score more than equal to 36 and less than or equal to 45.
4. Individuals with Perceived Stress Score more than or equal to 20.
5. Having atleast 2 of the following 5 metabolic risk factors:
- Waist circumference: In Men, More than or equal to 102 cm (40.15 inches) and in women more than or equal to 88 cm (34.65 inches).
- Triglycerides More than 150 mg per dL.
- Systolic blood pressure (SBP) more than or equal to 130 mm Hg and / or Diastolic blood pressure (DBP) more than or equal to 85 mm Hg.
- Fasting blood glucose more than or equal to 125 mg per dL.
- HDL level: In men, less than 40 mg per dL and in Women less than 50 mg per dL.
6. Individuals willing to provide signed consent. |
|
| ExclusionCriteria |
| Details |
1. Individuals on strict vegetarian diet.
2. Individuals with fasting blood sugar more than or equal to 160 mg per dl.
3. Individuals currently hospitalized or planned for admission.
4. Individuals currently undergoing treatment with any other drugs such as insulin, corticoids, and non-steroidal anti-inflammatory drugs for more than 15 days.
5. Individuals undergoing treatment of chemotherapy and/or suffering from AIDS, hepatitis, pregnancy are precluded from the study.
6. Individuals allergic to components of this nutraceutical formulation.
7. Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin or mineral supplements.
8. Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
9. Abnormal Thyroid Stimulating Hormone (TSH) value which is less than 0.40 or more than 4.50 micro IU per mL.
10. Diagnosed cases of Type II Diabetes Mellitus with medication.
11. Hypertensive defined as SBP more than or equal to 160 mm Hg and or DBP more than or equal to 100 mm Hg with anti-hypertensives.
12. Individuals taking anti-hypertensives
13. Individuals with dyslipidemia on medication.
14. Females in peri-menopausal state (Irregular menstrual period in last 6 months).
15. Females on Hormone Replacement Therapy.
16. Individuals with a history of or complications from inflammatory conditions.
17. Use of another investigational product within 3 months of the screening visit.
18. Individuals with a history of or complications from malignant tumors.
19. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
20. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
21. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men.
22. Females who are pregnant or planning to be pregnant or lactating or taking any oral contraceptives.
23. Any condition that could, in the opinion of the investigator, preclude the individual’s ability to successfully and safely complete the study or that may confound study outcomes. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of IP on Glucose Metabolism as assessed by change in serum fasting glucose levels |
Day 0 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of IP on Fat metabolism as assessed by serum lipid profile |
Day 0 and Day 90 |
| To assess the effect of IP on physical energy as assessed by energy VAS |
Day 0, Day 14, Day 30, Day 60 and Day 90 |
| To assess the effect of IP on Fatigue level as assessed by Fatigue Severity Scale (FSS) |
Day 0, Day 14, Day 30, Day 60 and Day 90 |
| To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire Scale |
Day 0, Day 30, Day 60 and Day 90 |
| To assess the effect of IP on Sleep as assessed by Pittsburg Sleep Quality Index |
Day 0, Day 14, Day 30, Day 60 and Day 90 |
| To assess the effect of IP on Stress perception as assessed by the Cohen Perceived Stress score |
Day 0, Day 14, Day 30, Day 60 and Day 90 |
| To assess the efficacy of IP on Future assessment of vitality related biomarkers (blood sample will be collected and analyzed post-hoc) |
Day 0, Day 30 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
12/09/2024 |
| Date of First Enrollment (Global) |
29/01/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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, feasibility study
to
evaluate efficacy of dietary ingredients in vitality & metabolic factors in
healthy individuals. Approximately 54 subjects aged between ≥ 40 and ≤ 60 years
will be screened and 36 participants (12 in each arm) are to be randomized.
Both the IP and placebo study arms will have 10 completed subjects
in each arm after accounting for the screening failure and dropout/withdrawal
rate of 30% and 17% respectively (Total 30 completers). The treatment duration
for all the study subjects will be 90 days. |