Efficacy of a pain relief formulation RHULEAVE-K in Adults with Exercise Induced Acute Musculoskeletal Pain.
- Registration Number
- CTRI/2020/06/025601
- Lead Sponsor
- Arjuna Natural Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 232
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.
4.Willing to give voluntary informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SPID6 (Sum of Pain intensity difference) using NRS (at rest)Timepoint: Time Frame: each 30 min post-dose censored at 6hrs
- Secondary Outcome Measures
Name Time Method Earliest onset of analgesia (perceived pain relief and meaningful pain relief)Timepoint: From post-dose to censored at 6hrs;McGill Short Form QuestionnaireTimepoint: Screening and after 6h.;SPID6 (Sum of Pain intensity difference) using NRS (at movement and pressure)Timepoint: Time Frame: each 30 min post-dose censored at 6hrs;TOTPAR6 (Total Pain Relief) 4.PRS (at rest, movement and pressure)Timepoint: each 30 min post-dose censored at 6hrs