Efficacy of TF1, & TF2 in Adult Subjects with exercise induced acute musculoskeletal pain

Phase 2

Completed

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 â€“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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Mean change in SPID6 hours	Intervals of 1hr - 0,1,2,3,4,5,6 hours.

Secondary Outcome Measures

Name	Time	Method
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.

Locations (1): Mewa Choudhary Memorial Hospital
🇮🇳
Jhansi, UTTAR PRADESH, India
Mewa Choudhary Memorial Hospital
🇮🇳Jhansi, UTTAR PRADESH, India
Dr Alok Agarwal
Principal investigator
8004911891
dralokagarwal1982@gmail.com