Phase 3 N=80 Randomized Double-blind Treatment

Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia

Sarcopenia · Geriatric · Muscle Mass · Muscle Strength · Physical Performance

Bottom Line

View on ClinicalTrials.gov: NCT05869383 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: IGF-1 Levels — 78.92; 77.08 ng/dl

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ophiochepalus striatus extract (Drug); Placebo (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Universitas Sriwijaya
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY IGF-1 Levels	78.92; 77.08	—
PRIMARY IL-6 Levels	36.47; 44.51	—

Summary

The goal of this Clinical Trial is to analyze effect of Ophiochepalus striatus extract on serum IGF-1 and IL-6 levels in elderly patients with sarcopenia. The main questions it aims to answer are: 1. Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia? 2. Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia? 3. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks reduce the SARC-F score in elderly people with sarcopenia? 4. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia? 5. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia? 6. Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia? Participants will: 1. Consume Ophiochepalus striatus extract 2x5 grams a day. 2. Checked blood before and after the intervention. 3. Measured muscle mass, muscle strength, and physical performance before and after the intervention.

Eligibility Criteria

Inclusion Criteria

Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: 3 times the upper limit of normal value
Impaired kidney function with a glomerular filtration rate 10)
History of hypersensitivity to Ophiocephalus striatus
Refuse to participate in research

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Data sourced from ClinicalTrials.gov (NCT05869383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.