A randomised, placebo-controlled, double blind clinical trial to test whether study drug could decrease damage from oxidative stress and inflammation related to acute muscle injury induced by eccentric continuous exercise.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity.
Study Overview
Brief Summary
Delayed onset muscle soreness (DOMS) is a familiar experience for the elite or novice athlete. Symptoms can range from muscle tenderness to severe debilitating pain. The mechanisms, treatment strategies, and impact on athletic performance remain uncertain, despite the high incidence of DOMS. DOMS is most prevalent at the beginning of the sporting season when athletes are returning to training following a period of reduced activity. DOMS is also common when athletes are first introduced to certain types of activities regardless of the time of year.
This problem can be trounced by innovative Curcumin preparation. It has been inferred that the test compound shows a concentration dependent DPPH free radical scavenging activity indicating its antioxidant potential equivalent to ascorbic acid. Based on the result in the study, it was concluded that the bio available curcumin-“cureit†could be a good source of natural antioxidant.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age: more than 20 years 2.Subjects will be healthy, moderately active (regular aerobic exercise for at least 4 hours per week), non-smoking volunteers with no known musculoskeletal pathology.
- •3.Subjects should have a maximal oxygen consumption (VO2max) of at least 35 ml/kg, as assessed by the maximal treadmill exercise test.
- •4.Subjects willing to sign an informed consent and adhere to all protocol requirements.
Exclusion Criteria
- •1.Treatment with anti-inflammatory/analgesic/antioxidant drugs in the previous month, 2.Abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious process and presence of any known disease.
- •3.Pregnancy or breast feeding 4.Current alcoholism or drug abuse 5.Allergies to one of the component substances in the trial 6.medication (active medication) 7.Participation in another clinical trial less than 3 months previously.
Outcomes
Primary Outcomes
To assess the efficacy of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity.
Time Frame: Screening visit - day-7 day1 day2 day3 and day4
Secondary Outcomes
- To assess the safety of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity.