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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control group get placebo 2x5 grams a day for 14 days |
|
| Ophiochepalus striatus extract | Experimental | Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophiochepalus striatus extract | Drug | Ophiochepalus striatus extract 2x5 grams |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 Levels | IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3. | 2 weeks |
| IL-6 Levels | IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nur Riviati | Mohammad Hoesin General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Hoesin Central General Hospital | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38525752 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Control group get placebo 2x5 grams a day for 14 days Placebo: Placebo 2x5 grams |
| FG001 | Ophiochepalus Striatus Extract | Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2023 |
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Both participant and investigator dont know the intervention that have been given.
| Placebo | Drug | Placebo 2x5 grams |
|
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Control group get placebo 2x5 grams a day for 14 days Placebo: Placebo 2x5 grams |
| BG001 | Ophiochepalus Striatus Extract | Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IGF-1 Levels | IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3. | Posted | Mean | Standard Deviation | ng/dl | 2 weeks |
|
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| |||||||||||||||||||||||||||||
| Primary | IL-6 Levels | IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69. | Posted | Mean | Standard Deviation | pg/dl | 2 weeks |
|
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14 days follow up during intervention period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Control group get placebo 2x5 grams a day for 14 days Placebo: Placebo 2x5 grams | 0 | 38 | 0 | 38 | 6 | 38 |
| EG001 | Ophiochepalus Striatus Extract | Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams | 0 | 40 | 0 | 40 | 8 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subjective complaint | Gastrointestinal disorders | Systematic Assessment | Nausea |
| |
| Subjective complaint | Gastrointestinal disorders | Systematic Assessment | Vomiting |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nur Riviati | Sriwijaya University | +6281377671384 | eviqodir@yahoo.com |
| Jan 4, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Jan 4, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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