SarcopeniaPhase 2/3NCT05869383
Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
A Phase 2/3 study testing Ophiochepalus striatus extract in people with Sarcopenia and Geriatric, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Geriatric, Muscle Mass
- What is being tested?
- Ophiochepalus striatus extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2023to 30 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: <7.0kg/m2, women: <5.7kg/m2 plus low muscle strength using a handgrip dynamometer, men: <28kg , female : <18kg or low physical performance using the 6 meter walk test; <1 meter/second.
Who cannot join
- Chronic liver disease (cirrhosis of the liver) or severe liver dysfunction or increased SGPT> 3 times the upper limit of normal value
- Impaired kidney function with a glomerular filtration rate <30 ml/minute without hemodialysis
- Acute phase of illness (eg infection, acute arthritis, acute stroke, trauma)
- Malignancy
- Depression according to the geriatric depression scale (Geriatric Depression Scale score> 10)
- History of hypersensitivity to Ophiocephalus striatus
- Refuse to participate in research
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Mohammad Hoesin Central General Hospital
Palembang, South Sumatera, 30126
About this study
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:
- Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia?
- Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
- 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?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia?
- Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?
Read more
Participants will:
- Consume Ophiochepalus striatus extract 2x5 grams a day.
- Checked blood before and after the intervention.
- Measured muscle mass, muscle strength, and physical performance before and after the intervention.
- Conditions
- Sarcopenia, Geriatric, Muscle Mass, Muscle Strength, Physical Performance
- Being tested
- Ophiochepalus striatus extract, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophiochepalus striatus extractDrug
Also called VipAlbumin
Ophiochepalus striatus extract 2x5 grams
PlaceboDrug
Also called Placebo contain maltodextrin
Placebo 2x5 grams
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control group get placebo 2x5 grams a day for 14 days Receives: Drug: Placebo |
| Ophiochepalus striatus extract | Experimental | Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days Receives: Drug: Ophiochepalus striatus extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 Levels
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
Measured: 2 weeks
IL-6 Levels
IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Riviati, Universitas Sriwijaya
- Investigators
- Nur Riviati, Principal investigator, Mohammad Hoesin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869383
- Sponsor's protocol ID
- D.XVIII.6.11/ETIK/36/2023
- Status last verified
- Jan 2025
- First submitted
- 11 May 2023
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riviati N, Legiran L, Saleh I, Indrajaya T, Ali Z, Irfannuddin, Probosuseno. Ophiocephalus striatus Extract Supplementation Decreases Serum IL-6 Levels in Older People with Sarcopenia-A Single-Center Experience. Geriatrics (Basel). 2024 Mar 7;9(2):35. doi: 10.3390/geriatrics9020035.
PubMed 38525752
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
- ClinicalTrials.gov ID
- NCT05869383
- Acronym / sponsor ID
- D.XVIII.6.11/ETIK/36/2023
- Conditions
- Sarcopenia, Geriatric, Muscle Mass, Muscle Strength, Physical Performance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia?
- Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
- 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?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia?
- Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?
Participants will:
- Consume Ophiochepalus striatus extract 2x5 grams a day.
- Checked blood before and after the intervention.
- Measured muscle mass, muscle strength, and physical performance before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboControl group get placebo 2x5 grams a day for 14 days |
| Ophiochepalus striatus extract | Experimental | Drug: Ophiochepalus striatus extractIntervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: <7.0kg/m2, women: <5.7kg/m2 plus low muscle strength using a handgrip dynamometer, men: <28kg , female : <18kg or low physical performance using the 6 meter walk test; <1 meter/second.
Key exclusion criteria (7 listed)
- Chronic liver disease (cirrhosis of the liver) or severe liver dysfunction or increased SGPT> 3 times the upper limit of normal value
- Impaired kidney function with a glomerular filtration rate <30 ml/minute without hemodialysis
- Acute phase of illness (eg infection, acute arthritis, acute stroke, trauma)
- Malignancy
- Depression according to the geriatric depression scale (Geriatric Depression Scale score> 10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophiochepalus striatus extractAlso: VipAlbuminOphiochepalus striatus extract 2x5 grams | Drug | Ophiochepalus striatus extract |
| PlaceboAlso: Placebo contain maltodextrinPlacebo 2x5 grams | Drug | Placebo |
Primary outcome
IGF-1 Levels
Time frame: 2 weeks
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
IL-6 Levels
Time frame: 2 weeks
IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38525752Riviati N, Legiran L, Saleh I, Indrajaya T, Ali Z, Irfannuddin, Probosuseno. Ophiocephalus striatus Extract Supplementation Decreases Serum IL-6 Levels in Older People with Sarcopenia-A Single-Center Experience. Geriatrics (Basel). 2024 Mar 7;9(2):35. doi: 10.3390/geriatrics9020035.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Riviati principal investigator
Mohammad Hoesin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ophiochepalus striatus extract in people with Sarcopenia and Geriatric, run by Universitas Sriwijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 Levels (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.