| CTRI Number |
CTRI/2025/01/079598 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to evaluate the safety and efficacy of Capsimax on exercise performance. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo-Controlled,
Cross Over Study to Evaluate the Safety and Efficacy of Capsimax on
Exercise Performance. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-OA-159, Version 1.0 dated 14 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Kumar Rawal |
| Designation |
Musculoskeletal and Sports Physiotherapist |
| Affiliation |
Prehab Musculoskeletal and Sports Health Clinics |
| Address |
Room No. 01, Ground Floor, Mahakavi Kuvempu Metro Station, 2934,
Triveni Arcade, Second Floor, 2nd Stage,
D Block Mahakavi Kuvempu Road,
Landmark: Rajajinagar,
Bangalore
KARNATAKA
560010
India |
| Phone |
998685565 |
| Fax |
|
| Email |
drarunkumarrawal.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.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 |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| OmniActive Health Technologies, India
Phoenix House, T- 8, A Wing
462 Senapati Bapat Marg, Lower Parel
Mumbai - 400 013, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
OmniActive Health Technologies, India |
| Address |
Phoenix House, T- 8, A Wing
462 Senapati Bapat Marg, Lower Parel
Mumbai - 400 013, Maharashtra, 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 Arun Kumar Rawal |
Prehab Musculoskeletal & Sports Health Clinics |
Room No. 1, Ground Floor, Mahakavi Kuvempu Metro Station, 2934,
Triveni Arcade, Second Floor, 2nd Stage,
D Block Mahakavi Kuvempu Road,
Landmark: Rajajinagar
Bangalore
KARNATAKA |
998685565
drarunkumarrawal.ct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal hematological and biochemical parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsimax |
100 mg capusle once a day for 7 days |
| Comparator Agent |
Placebo |
100 mg capusle once a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Subjects must have a BMI of 18.5 to 29.9 kg/m2 (both limits inclusive).Subjects must have greater than one year of resistance training experience at a frequency of 2 days per week.Subjects must be familiar with the barbell back squat exercise.Subjects must be free of any physical limitations or chronic illness that may affect performance.Subjects must be free of any medications.Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.Subject willing to provide written consent.Subjects willing to refrain from vigorous physical activity/ strenuous exercise 24 hours prior to test days.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy
prohibitions, and be able to complete the study. |
|
| ExclusionCriteria |
| Details |
Subjects having hypersensitivity or history of allergy to the study product.Subjects with uncontrolled hypertension (SBP greather than 160 mmHg or DBP greater than 100 mmHg) at screening.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition)and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the
conduct of the study by the investigator.Subjects with any other medical condition that might adversely impact the safety of the study
participants or confound the study results.Subjects with inability to swallow soft gel capsules.Subjects who require medications.Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.Subjects with a history of drug and or alcohol abuse at the time of enrolment.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in efficacy parameters of Peak power and rate of force development during an isometric strength test,performance during the barbell back squat exercise protocol and performance during the push-up protocol. |
Baseline, Day 7, Day 15 and Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Velocity related measure and Resting energy expenditure.
|
Baseline, Day 7, Day 15 and Day 21 |
Mean change in Nitric oxide bioavailability and skeletal muscle oxygenation
|
Baseline, Day 7, Day 15 and Day 21 |
Mean change in Agility and reaction time
|
Baseline, Day 7, Day 15 and Day 21 |
| Mean change in VAS for feelings of fatigue and pain and Rating of perceived exertion |
Baseline, Day 7, Day 15 and Day 21 |
| Mean change in Glucagon-like peptide-1 |
Baseline, Day 7 and Day 21 |
| Overall safety |
Baseline, Day 7, Day 15 and Day 21 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is a prospective, double blind, randomized, placebo-controlled, cross-overstudy. The subjects will be explained about the study procedures, the risks and discomforts, the investigational product (IP) and other alternative supplements. Informed consent will be obtained from subjects who are willing to participate in the study. After the informed consent process, demographic details will be obtained. The subjects’ anthropometric data will be obtained The subjects who fulfil the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. The subjects shall be randomly (double blind) assigned in 1:1 ratio to one of the treatment groups. A wash-out period of 7 ± 1 day will be followed for cross-over of treatments.Statistical comparisons for efficacy shall be made between test product and placebo.The total study duration for the clinical part shall be a maximum of 24 days which includes 3 days of screening period, 14 days of treatment period and 7 days of washout period. |