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Prospective, double blind, placebo controlled, randomized, interventional study to evaluate the efficacy and safety of GreMinTM as a supplement in accelerating healing of experimentally induced acute muscle injury in healthy volunteers.

Prospective, double blind, placebo controlled, randomized, interventional study to evaluate the efficacy and safety of GreMinTM as a supplement in accelerating healing of experimentally induced acute muscle injury in healthy volunteers.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029407
Enrollment
16
Registered
2020-11-26
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: Gremin Capsule: Gremin is a herbal formula which exert anti inflammatory and antioxidant effect in addition to improving stamina and endurance. IP will be taken daily for 09 days. GreM

Sponsors

Zeus Hygia Lifesciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy subjects, moderately active (regular aerobic exercise for at least 4 hours per week), non-smoking volunteers with no known musculoskeletal pathology. Subjects with a maximal oxygen consumption (VO2max) of at least 35 ml/kg, as assessed by the maximal treadmill exercise test Subject who is identified as healthy as per clinical judgement of principal investigator Subjects willing to comply to study procedure and sign written informed consent

Exclusion criteria

Exclusion criteria: Treatment with anti-inflammatory/analgesic/antioxidant drugs in the previous month History of abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious process and presence of any known disease in last 3 months. Current alcoholism or drug abuse Allergies to one of the component substances in the trial medication (active medication) Participation in another clinical trial less than 6 months previously. Subjects with open wounds Subjects with injury involving skeletal system or deep soft tissue injury in last 3 months Subjects on steroids or ergogenic users since past 3 months Subjects with uncontrolled systemic disease since past 3 months. Subject with neurological disorders since past 3 months Any active chronic health condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study.

Design outcomes

Primary

MeasureTime frame
1. Recovery from muscle damage due to sports injury 2. Increased EnduranceTimepoint: baseline to end of treatment

Secondary

MeasureTime frame
1. Occurrence of any AE or SAE during the study. 2. Occurrence of any clinically significant abnormality as per the Principal Investigator in the following safety marker test: Heart Rate Abbreviated POMS questionnaire Respiratory Rate Timepoint: Visits 2, Visit 3 and Visit 4 and Visit 5.

Countries

India

Contacts

Public ContactShankaranarayanan J

ZeusHygia LifeSciences Pvt Ltd

shankar@zeushygia.com

Outcome results

None listed

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