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A 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.

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. - DOMS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014174
Enrollment
30
Registered
2018-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Cureit: 500mg capsule once daily Control Intervention1: Placebo: Capsule 500mg once daily

Sponsors

Plant Lipids P limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity. Timepoint: Screening visit - day-7 day1 day2 day3 and day4

Secondary

MeasureTime frame
To assess the safety of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity. Timepoint: Screening visit - day-7 day1 day2 day3 and day4

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt Ltd

pm@bioagiletherapeutics.com9980107723

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026