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

Sponsor
Universitas Sriwijaya (Other)
Overall Status
Recruiting
CT.gov ID
NCT05869383
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ophiochepalus striatus extract
  • Drug: Placebo
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control Group

Control group get placebo 2x5 grams a day for 14 days

Drug: Placebo
Placebo 2x5 grams
Other Names:
  • Placebo contain maltodextrin

    		•
    Experimental: Intervention group

    Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days

    Drug: Ophiochepalus striatus extract
    Ophiochepalus striatus extract 2x5 grams
    Other Names:
  • VipAlbumin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IGF-1 Levels [2 weeks]

      IGF-1 serum Levels

    2. IL-6 levels [2 weeks]

      IL-6 serum levels

    Secondary Outcome Measures

    1. SARC-F Score [2 weeks]

      SARC-F Score

    2. Muscle Mass [2 weeks]

      As Appendicular Skeletal Muscle Index

    3. Muscle Strength [2 weeks]

      measured with handgrip strength

    4. Physical performance [2 weeks]

      Measured with Time Up and Go test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohammad Hoesin Central General Hospital Palembang South Sumatera Indonesia 30126

    Sponsors and Collaborators

    • Universitas Sriwijaya

    Investigators

    • Principal Investigator: Nur Riviati, Mohammad Hoesin General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nur Riviati, Internist Geriatrician, Universitas Sriwijaya
    ClinicalTrials.gov Identifier:
    NCT05869383
    Other Study ID Numbers:
    • D.XVIII.6.11/ETIK/36/2023
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 22, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sarcopenia

    Study Results

    No Results Posted as of May 22, 2023