Trial Outcomes & Findings for Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia (NCT NCT05869383)
NCT ID: NCT05869383
Last Updated: 2025-01-31
Results Overview
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
80 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-01-31
Participant Flow
Participant milestones
| Measure |
Placebo
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
n=40 Participants
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Continuous
|
71 years
n=99 Participants
|
70 years
n=107 Participants
|
71 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Indonesia
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
78 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksIGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
Outcome measures
| Measure |
Placebo
n=38 Participants
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
n=40 Participants
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
|---|---|---|
|
IGF-1 Levels
|
78.92 ng/dl
Standard Deviation 21.7
|
77.08 ng/dl
Standard Deviation 20.9
|
PRIMARY outcome
Timeframe: 2 weeksIL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
Outcome measures
| Measure |
Placebo
n=38 Participants
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
n=40 Participants
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
|---|---|---|
|
IL-6 Levels
|
36.47 pg/dl
Standard Deviation 17.45
|
44.51 pg/dl
Standard Deviation 23.57
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ophiochepalus Striatus Extract
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams
|
Ophiochepalus Striatus Extract
n=40 participants at risk
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams
|
|---|---|---|
|
Gastrointestinal disorders
Subjective complaint
|
5.3%
2/38 • Number of events 2 • 14 days follow up during intervention period
1. Serious Adverse Events: death, a life-threatening adverse event, and inpatient hospitalization. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment. 2. Other Adverse Events: Adverse events that are not Serious Adverse Events.
|
5.0%
2/40 • Number of events 2 • 14 days follow up during intervention period
1. Serious Adverse Events: death, a life-threatening adverse event, and inpatient hospitalization. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment. 2. Other Adverse Events: Adverse events that are not Serious Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place