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Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Phase 2, PHASE3 trial testing Ophiochepalus striatus extract in Sarcopenia in 80 participants. Completed in 30 October 2023.
| Lead sponsor | Universitas Sriwijaya |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2023 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 October 2023 |
| Sites | 1 location across Indonesia |
Universitas Sriwijaya — full company profile →
60 and older, any sex, with Sarcopenia or Geriatric. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 78.92 | ± 21.7 |
| Ophiochepalus Striatus Extract | 77.08 | ± 20.9 |
IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 36.47 | ± 17.45 |
| Ophiochepalus Striatus Extract | 44.51 | ± 23.57 |
Time frame: 14 days follow up during intervention period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Ophiochepalus Striatus Ext… |
|---|---|---|---|
| Subjective complaint | Gastrointestinal disorders | — | — |
| Subjective complaint | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT05869383 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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