A Randomized Placebo Controlled Double Blinded Multicenter Study to Assess the Efficacy of RHULEAVE-K in Adult Subjects with Exercise Induced Acute Musculoskeletal Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 232
- Locations
- 6
- Primary Endpoint
- SPID6 (Sum of Pain intensity difference) using NRS (at rest)
Study Overview
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 of the screening procedure will be an NRS score (at rest) of 5 or above. McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The subjects will be asked specific history of pain like date of occurence, time of onset, duration of pain, part of the body affected, history of similar pain in the past during exercise (<24h, 24-48h, >48h), its severity, duration of pain, any treatment taken etc. Any underlying condition which will affect the current pain or evaluation of treatment will be sought for and excluded by history and physical examination. The participants will then be randomized into either the treatment group or the placebo group.
Post dose for every 30 minutes interval up to 6hrs the participant will be asked to indicate their resting pain intensity and pain relief, and also their pain on movement and pressure using the NRS and PRS scale. McGill-SF questionnaire will be taken at the end of the study to evaluate quality of pain.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Adult subject, Male or female between 18-65 years of age.
- •2.A score of 5cm or above on the NRS ( at rest).
- •3.Subjects having Exercise Induced Acute Musculoskeletal Pain which occurred within 24 hours before presentation.
- •(musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital.
Exclusion Criteria
- •1.Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management of acute injuries of ligaments, tendons, or muscles, painful complicated acute soft tissue injury of the upper or lower extremity, including.
- •Subjects with Grade 2 & 3 sprain or strain or Muscle cramps due to dehydration.
- •2.Subjects with known history of osteoarthritis and rheumatoid arthritis.
- •3.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
- •4.Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
- •5.Subjects underlying dermatitis or dermatosis associated with the injury.
- •6.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 to study or during the study.
- •7.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
- •8.Any kind of neuralgic pain, headache and/or chronic pain 9.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
- •10.A known pregnancy or lactation 11.Previous history of gastro-intestinal haemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding.
- •12.Subjects who are severe smokers and drinkers 13.Received an investigational product or participated in an investigational study within a period of 30 days prior to receiving study medication.
- •14.Scheduled elective surgery or other invasive procedures during the period of study participation.
- •15.Subjects had a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV).
- •16.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
Outcomes
Primary Outcomes
SPID6 (Sum of Pain intensity difference) using NRS (at rest)
Time Frame: Time Frame: each 30 min post-dose censored at 6hrs
Secondary Outcomes
- Earliest onset of analgesia (perceived pain relief and meaningful pain relief)(From post-dose to censored at 6hrs)
- SPID6 (Sum of Pain intensity difference) using NRS (at movement and pressure)(Time Frame: each 30 min post-dose censored at 6hrs)
- TOTPAR6 (Total Pain Relief) 4.PRS (at rest, movement and pressure)(each 30 min post-dose censored at 6hrs)
- McGill Short Form Questionnaire(Screening and after 6h.)