None listed
Conditions
Interventions
None listed
Sponsors
AceOne RS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy children of both genders, aged 2 to 10 years, at the time of screening. 2.Children assessed as healthy based on medical history, physical examination, vital signs, and laboratory investigations, as determined by the Investigator. 3.Parent(s) or legally acceptable guardian(s) willing and able to provide written informed consent prior to initiation of any study-related procedures. 4.Parent(s) or legally acceptable guardian(s) willing to abide by and comply with the study protocol. 5.Parent(s) or legally acceptable guardian(s) willing to comply with study procedures, including study visits, administration of investigational product, and completion of participant diary. 6.Child whose parent(s) or legally acceptable guardian(s) agree to maintain a participant diary and report any adverse events during the study period.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergy to mulberry leaf extract or related plant-derived products. 2.Presence of any acute or chronic medical condition that, in the opinion of the investigator, may interfere with study participation or safety evaluation (including but not limited to significant hepatic, renal, cardiovascular, gastrointestinal, metabolic, or immunological disorders). 3.History of clinically significant gastrointestinal disorders that may affect absorption or tolerability of the investigational product. 4.Abnormal clinically significant laboratory findings at screening, as determined by the investigator. 5.History of psychiatric or neurological disorders requiring ongoing medical treatment. 6.Current use of medications or supplements that may interfere with study assessments or safety evaluation, as judged by the investigator. 7.Participation in another clinical trial or receipt of an investigational product within 30 days prior to enrolment. 8.Any condition that, in the opinion of the investigator, makes the participant unsuitable for study participation or may compromise participant safety or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Safety of the investigational products, assessed by the incidence, nature, severity, and relationship of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) from baseline through the end of the study. -Changes in clinical laboratory safety parameters from baseline to end of treatment, including: - Complete Blood Count (CBC) - Liver Function Tests (LFT) - Renal Function Tests (RFT) - Fasting Blood Glucose (FBG) - Lipid Profile - Urinalysis Timepoint: Day 1 - Visit 1 - Baseline Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 Day 90 2 days - Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of the investigational products, assessed throughout the study based on: - Feeding behaviour - Parent or legally acceptable guardian reported acceptabilityTimepoint: Day 1 - Visit 1 - Baseline Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 Day 90 2 days - Visit 4; Changes in vital signs (temperature, heart rate, and respiratory rate) from baseline to each scheduled follow-up visit and end of treatment.Timepoint: Day 1 - Visit 1 - Baseline Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 Day 90 2 days - Visit 4; Compliance with study product administration, assessed by study product accountability, Parent/legal guardian reported administration records and participant diary review.Timepoint: Day 1 - Visit 1 - Baseline Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 Day 90 2 days - Visit 4 | — |
Countries
India
Contacts
Public ContactMs Sathyavathi LM
Samahitha Research Solutions
Outcome results
None listed