| CTRI Number |
CTRI/2021/12/038892 [Registered on: 24/12/2021] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| 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 clinical study to evaluate the efficacy and safety of Turmeric Capsules (TurmXtra 60 N) Delayed onset muscle soreness in healthy recreationally active subjects |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the efficacy and safety of TurmXtra 60N in Delayed Onset Muscle Soreness in healthy recreationally active subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-21-041,Version: 01, Date: 23 Nov 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajanna M |
| Designation |
BAMS, MD (Ayurveda), Consultant Physician |
| Affiliation |
Arogyavardhini Ayurvedic Centre |
| Address |
Arogyavardhini Ayurvedic Centre, Ayurvedic department, Consulting Physician Division, Room No 01, Ground Floor, Centre No 2, 5th Cross, Giddappa layout, Nehru Road, Kammanahalli Thomas town Post
Nil
Bangalore
KARNATAKA
560084
India |
| Phone |
8660620501 |
| Fax |
- |
| Email |
mdrrajanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channa Basavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Medical Monitoring Divison, Room No 301, 3rd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal.
Nil
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
- |
| Email |
Channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijay Bhaskar |
| Designation |
Director- Clinical Development |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Clinical Operations Divison, Room No 302,3rd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal.
Nil
Bangalore
KARNATAKA
560092
India |
| Phone |
636675282 |
| Fax |
- |
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Ltd, Unit 703, 704,7th floor, Hubtown Solaris, N.S.Phadke Marg, Andheri (East), Mumbai-400069, Maharashtra, India and Laila Nutraceuticals, 40-15-14,Brindavan Colony, Vijayawada – 520 010, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Ltd |
| Address |
Unit 703,704,7th floor,Hubtown solaris,N.S.Phadke Marg,Andheri(east),Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutraceuticals |
40-15-14, Brindavan Colony, Vijayawada – 520 010, Andhra Pradesh, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajanna M |
Arogyavardhini Ayurvedic Centre |
Arogyavardhini Ayurvedic Centre,#2, 5th Cross, Giddappa layout, Nehru Road, Kammanahalli, Thomas town Post
Bangalore
KARNATAKA |
8660620501
-
mdrrajanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Delayed Onset Muscle Soreness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsule |
One Capsule daily for 33 days |
| Intervention |
TurmXtra 60N (Water Dispersible Turmeric Extract) Capsule 250 mg |
One capsule (250 mg) once daily for 33 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects 18 – 35 years of age with a Body Mass Index (BMI) of 18 to 30 kg/m2.
2.Healthy, moderately active [regular aerobic exercise for at least 150 min per week for past 3 months], non-smoking subjects with no known musculoskeletal pathology.
3.Subjects who have been vaccinated with COVID 19 (Two doses) vaccine.
4.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
5.Results of screening tests within normal range or considered not clinically significant by the Principal Investigator.
6.Willing to sign the informed consent and comply with study procedure.
7.willing to abstain from use of analgesics / NSAIDs during entire treatment period
|
|
| ExclusionCriteria |
| Details |
1.Female subjects, who are pregnant, breast feeding or planning to become pregnant.
2.Subjects with Covid-19 symptoms.
3.Subject has known allergy to any compound present in the study product.
4.Subjects regularly involved in strength training.
5.History / Presence of frequent use of OTC NSAIDS or / and analgesic agents.
6.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc) /Nicotine/Caffeine dependence.
7.History / presence of psychosis, major depressive disorder or other clinically significant psychiatric disorder.
8.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
9.History of surgery or trauma affecting the knee.
10.History / presence of any neurological or muscular disorders that may affect muscle strength.
11.History / presence of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, gastrointestinal, hepatic, renal, metabolic, and ophthalmologic disorders; presence of HIV and AIDS; taking regular prescription pharmacological agents.
12.Subjects on multivitamins/herbal and/or turmeric supplements/ any other wellness product.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Pain Visual Analogue Scale (VAS) [100 mm] score from baseline to end of the treatment. |
Time Points: Day 29 (baseline, immediately post work out and 12 hours post work out), Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out)treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Delayed-onset muscle soreness (DOMS) score from baseline to end of the treatment
2.Serum creatine kinase (CK) and LDH from baseline to end of the treatment
3. Treatment emergent adverse events (AEs), frequency and severity
4. Subject’s and physician’s global assessment of therapy at end of the treatment visit |
1.Day 29 (baseline, immediately post work out and 12 hours post work out), Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out)
2. Day 29 baseline, Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out)
3. Throughout the study
4. End of the study visit |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2021 |
| Date of Study Completion (India) |
07/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Total 30 healthy recreationally active subjects will be enrolled in the study. They will be divided into two arms. i.e, active and placebo arm and followed up for 33 days. The primary objective of the study will be to evaluate the efficacy of turmeric extract (TurmXtra 60N) in recreationally active individuals.
|