None listed
Conditions
Interventions
Intervention1: TurmXtra 60N (Water Dispersible Turmeric Extract) Capsule 250 mg: One capsule (250 mg) once daily for 33 days
Control Intervention1: Placebo Capsule: One Capsule daily for 33 days
Sponsors
Inventia Healthcare Ltd
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects 18 ââ?¬â?? 35 years of age with a Body Mass Index (BMI) of 18 to 30 kg/m2. 2.Healthy, moderately active [regular aerobic exercise for at least 150 min per week for past 3 months], non-smoking subjects with no known musculoskeletal pathology. 3.Subjects who have been vaccinated with COVID 19 (Two doses) vaccine. 4.Female subjects of childbearing potential must be using a medically acceptable form of birth control. 5.Results of screening tests within normal range or considered not clinically significant by the Principal Investigator. 6.Willing to sign the informed consent and comply with study procedure. 7.willing to abstain from use of analgesics / NSAIDs during entire treatment period
Exclusion criteria
Exclusion criteria: 1.Female subjects, who are pregnant, breast feeding or planning to become pregnant. 2.Subjects with Covid-19 symptoms. 3.Subject has known allergy to any compound present in the study product. 4.Subjects regularly involved in strength training. 5.History / Presence of frequent use of OTC NSAIDS or / and analgesic agents. 6.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc) /Nicotine/Caffeine dependence. 7.History / presence of psychosis, major depressive disorder or other clinically significant psychiatric disorder. 8.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit. 9.History of surgery or trauma affecting the knee. 10.History / presence of any neurological or muscular disorders that may affect muscle strength. 11.History / presence of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, gastrointestinal, hepatic, renal, metabolic, and ophthalmologic disorders; presence of HIV and AIDS; taking regular prescription pharmacological agents. 12.Subjects on multivitamins/herbal and/or turmeric supplements/ any other wellness product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pain Visual Analogue Scale (VAS) [100 mm] score from baseline to end of the treatment.Timepoint: Time Points: Day 29 (baseline, immediately post work out and 12 hours post work out), Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out)treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Delayed-onset muscle soreness (DOMS) score from baseline to end of the treatment 2.Serum creatine kinase (CK) and LDH from baseline to end of the treatment 3. Treatment emergent adverse events (AEs), frequency and severity 4. Subjectââ?¬â?¢s and physicianââ?¬â?¢s global assessment of therapy at end of the treatment visitTimepoint: 1.Day 29 (baseline, immediately post work out and 12 hours post work out), Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out) 2. Day 29 baseline, Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out) 3. Throughout the study 4. End of the study visit | — |
Countries
India
Contacts
Public ContactT Vijay Bhaskar
In Vitro Research Solutions Pvt. Ltd.
Outcome results
None listed