| CTRI Number |
CTRI/2023/07/055271 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of TF1, & TF2 in Adult Subjects with exercise induced acute musculoskeletal pain |
|
Scientific Title of Study
|
A randomized double-blinded comparative efficacy study of TF1 and TF2 in Adult Subjects with exercise induced acute musculoskeletal pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-07PFK0623H4-WES16 version 1 Date 1 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Sooraj Rajasekharan Kartha |
| Designation |
Scientist- Clinical Research |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam
Ernakulam
KERALA
683101
India |
| Phone |
9847670997 |
| Fax |
|
| Email |
sooraj@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Private Ltd
Bank Road, Aluva Ernakulam 683101, India.
|
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Ltd |
| Address |
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam KERALA |
| Type of Sponsor |
Other [Neutraceutical] |
|
|
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 Alok Agarwal |
Mewa Choudhary Memorial Hospital |
Department of Orthopedics, Ground Floor, OPD No 2, Medical College, Opposite Gate No 2, MLB, Kanpur-Jhansi Hwy, Bundelkhand University-284128
Jhansi
UTTAR PRADESH |
8004911891
dralokagarwal1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nirmal Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
exercise induced acute musculoskeletal pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TF1 |
Turmeric Boswellia extract 1000mg for 1 day. |
| Comparator Agent |
TF2 |
Turmeric Boswellia extract 1000mg for 1 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult subject, Male or female between 18-65 years of age.
A score of 5 or above on the NRS.
Subjects having exercise induced acute musculoskeletal pain which occurred within 24 hours before presentation.
Willing to give voluntary informed consent. |
|
| ExclusionCriteria |
| Details |
Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. Subjects with Grade 2 & 3 sprain or strain or muscle cramps due to dehydration.
Pain originating from bone.
Subjects with known history of osteoarthritis and rheumatoid arthritis.
Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
Use of any oral or topical analgesic, antipyretic, sedative or anti-inflammatory treatment, Use of any topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetic products at the site of pain within 1 week prior study or during the study.
Any kind of neuralgic pain, headache and/or chronic pain
Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in SPID6 hours |
Intervals of 1hr - 0,1,2,3,4,5,6 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in TOTPAR6 hours |
Intervals of 1hr - 0,1,2,3,4,5,6 hours. |
| Mean change in Perceived pain relief & Meaningful pain relief using stop watch. |
Time to pain relief starting from 0hr & censored at 6hr. |
| Mean change in McGill Short Form Questionnaire |
Baseline & end of 6hr. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/07/2023 |
| Date of Study Completion (India) |
02/09/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria for the screening procedure will be an NRS score of 5 or above. McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The participants will then be randomized into either of the two groups. Post dose for every 1hr interval up to 6hrs the participant will be asked to indicate their resting pain intensity and pain relief, using the NRS and PRS scale. McGill-SF questionnaire will be taken at the baseline and end of the study (post 6 hr) to evaluate quality of pain. If there is need for rescue medication, then the subject will record pain intensity before taking rescue medication and the consumption recorded.
|