| CTRI Number |
CTRI/2019/05/019366 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
27/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Crossover designed, Placebo Controlled Study to evaluate the effects of supplement REPHYLL on delayed onset muscle soreness (DOMS) in humans. |
|
Scientific Title of Study
|
A Randomized, Double Blinded, Crossover designed, Placebo Controlled Study to evaluate the effects of supplement REPHYLL on delayed onset muscle soreness (DOMS) in humans |
| Trial Acronym |
DOMS-2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-016 version 1.0 dated 08 Mar 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajkumar Nikalje |
| Designation |
Consultant - Physician |
| Affiliation |
Consultant |
| Address |
Skinovate Clinic
302/303 Royal Avenue building
3rd floor Near Shivar garden Restaurant Pimple Saudagar
Pune
MAHARASHTRA
411027
India |
| Phone |
9028560535 |
| Fax |
|
| Email |
nikaljeraj80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayananda |
| Designation |
General Manager |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
Bioagile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore
Bangalore
KARNATAKA
560094
India |
| Phone |
|
| Fax |
|
| Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
Bioagile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore
Bangalore
KARNATAKA
560094
India |
| Phone |
|
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aurea Biolabs P Ltd |
| Address |
Kolenchery Cochin 682311 Kerala |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajkumar Nikalje |
Skinovate Clinic |
302/303 Royal Avenue building 3rd floor Near Shivar garden Restaurant Pimple Saudagar
Pune
MAHARASHTRA |
02065222284
nikaljeraj80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifepoint Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Delayed onset muscle soreness(DOMS) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A supplement |
500mg capsule to be taken once a day.
Total duration of therapy is 21days |
| Comparator Agent |
Placebo |
500 mg capsule to be taken once a day.
Total duration of therapy is 21days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Male |
| Details |
Subject has provided written and dated informed consent to participate in the study. Subject is willing and able to comply with the protocol. Subject is a male between 19 and 29 years of age, inclusive. Subject is in good health as determined by a health history questionnaire. Subject is untrained in resistance/power exercise |
|
| ExclusionCriteria |
| Details |
Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. Subject has a history of alcohol or other drug abuse in the past year. Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP> 140 and/or diastolic BP> 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. Subject has a known allergy or sensitivity to any ingredient in the test product. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. Subject has a history of difficulty swallowing large pills or tablets. Subject has used creatine within 9 weeks prior to screening. Subject has a history of orthopedic injury or surgery within the last year. Subject has any physical condition considered a contra-indication to the type of exercise performed in the study. Subject has had an abnormal resting ECG. Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in isometric strength Change in flexibility Change in blood parameters |
day1 day21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse event reports |
day1 day21 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2019 |
| Date of Study Completion (India) |
30/07/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Delayed-onset muscle soreness (DOMS) describes muscle pain and tenderness
that typically develop several hours post exercise and consist of predominantly
eccentric muscle actions, especially if the exercise is unfamiliar. Eccentric
exercise continues to receive attention as a productive means of exercise.
Coupled with this has been the heightened study of the damage that occurs in
early stages of exposure to eccentric exercise. This is commonly referred to as
delayed onset muscle soreness (DOMS). Muscle pain and tenderness
generally develop 24 hours after such exercise and are usually described as
delayed-onset muscle soreness (DOMS). DOMS remains uncertain,
it is generally accepted that DOMS is caused by inflammation of the damaged
muscle and/or connective tissue and the efflux of substances from the damaged
tissue to the extracellular space that sensitize the free nerve endings. |