None listed
Conditions
Interventions
Intervention1: Arm A_Test Arm - CurcuVail: Curcuma Longa Extract 125 mg Cellulose Capsule, orally twice a day.
Control Intervention1: Arm B_Placebo Arm - Matching Placebo: The placebo capsules are com
Sponsors
K Patel Phyto Extractions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing and able to provide written informed consent prior to any study related activities being performed. 2.Able and willing to comply with the protocol, including availability for all scheduled study visits. 3.Male and Female participants aged between 18 years to 40, both inclusive. 4.Participants with no known musculoskeletal pathology. 5.Women of childbearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the IP practicing any two acceptable methods of contraception. Acceptable methods of contraception Oral or parenteral injection, patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication Intrauterine device IUD or intrauterine system IUS Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent Male sterilization at least 6 months prior to the screening, should be the sole male partner for that participant Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation Total abstinence, partial abstinence is not acceptable
Exclusion criteria
Exclusion criteria: 1.Participants using systemic corticosteroids within 2 months of screening. 2.Participants with any other investigational drug within 1 month prior to randomization. 3.Participants with uncontrolled diabetes mellitus and hypertension. 4.Participants with known tuberculosis, ischemic heart disease, cancer, kidney failure. 5.Participants with a self-reported or medically documented history of Hepatitis B, Hepatitis C, or HIV infection will be excluded from participation in the study. 6.High alcohol intake 2 standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc Nicotine Caffeine dependence. 7.Current use of anticoagulants or antiplatelet agents other than low dose aspirin if clinically indicated and stable for 3 months. 8.Participants using medications anti inflammatory, analgesic, antioxidant drugs, nutritional products, and dietary supplements that may interfere with the study results, as determined by the investigators opinion. 9.Participants with a history of orthopaedic injury or surgery within the last year. 10.Known hypersensitivity to any of the ingredients of Test Product. 11.Participant has condition or is in a situation which, in the investigators opinion, may have put the Participant at a significant risk, may have confounded study results, or may have interfered significantly with the Participants participation in the study. 12.Pregnant, planning pregnancy or Lactating female Participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in muscle pain on numeric rating scale.Timepoint: The participant will be asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. Day 0 Baseline to Day 5 End of Treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Leg Press Performance Test Change in Pressure Pain Threshold PPT as measured by Algometer. Change in Knee Flexion Range of Motion ROM assessed using a Goniometer. Change in Global Assessment of overall improvement as evaluated by the Investigator & the Participant. Comparative assessment of requirement of Paracetamol or NSAIDs as rescue medicine Number of Participants & days required for complete muscle recovery Change in biomarkers of muscle damage, including Creatine Kinase CK, & Lactate Dehydrogenase LDH Change in inflammatory marker Interleukin6 IL6 Change in mid thigh circumference, measured at a standardized point midway between the greater trochanter & the lateral knee joint line.Timepoint: Day 0 Baseline to Day 5 end of treatment | — |
Countries
India
Contacts
Public ContactMr Rashmin Lad
Methics Clinical Solutions Private Limited
Outcome results
None listed