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

A randomized double-blinded comparative efficacy study of TF1 and TF2 in Adult Subjects with exercise induced acute musculoskeletal pain - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055271

Enrollment

Registered

2023-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: TF1: Turmeric Boswellia extract 1000mg for 1 day. Control Intervention1: TF2: Turmeric Boswellia extract 1000mg for 1 day

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Mean change in SPID6 hoursTimepoint: Intervals of 1hr - 0,1,2,3,4,5,6 hours.	—

Secondary

Measure	Time frame
Mean change in McGill Short Form QuestionnaireTimepoint: Baseline & end of 6hr.;Mean change in Perceived pain relief & Meaningful pain relief using stop watch.Timepoint: Time to pain relief starting from 0hr & censored at 6hr.;Mean change in TOTPAR6 hoursTimepoint: Intervals of 1hr - 0,1,2,3,4,5,6 hours.	—

Countries

India

Contacts

Public ContactSooraj Rajasekharan Kartha

Arjuna Natural Pvt Ltd

drbinu@arjunanatural.com09447818432

Outcome results