Dose Ranging and Pharmacodynamic Study to Evaluate the Effect on Lipid Profile of Oral Daily Administration of Forhidrol Bioactive Fraction (Hidelsa®)
Tahapan Penelitian : Complete
Sponsor:
PT Dexa Medica
Mitra Pelaksana:
PT Equilab International
No Registry
INA-41PQ2QN1
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 14-05-2022 |
| Outcome Primer | The change (delta) values of lipid profile (total cholesterol, LDL cholesterol, triglyceride and HDL cholesterol) after 8 weeks of daily treatment between the dose administration of 2x500 mg, 1x1000 mg and 2x1000 mg daily, The change will be presented in absolute and percentage value |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Dose Ranging and Pharmacodynamic Study to Evaluate the Effect on Lipid Profile of Oral Daily Administration of Forhidrol Bioactive Fraction (Hidelsa®) |
| Judul Penelitian Ilmiah | Dose Ranging and Pharmacodynamic Study to Evaluate the Effect on Lipid Profile of Oral Daily Administration of Forhidrol Bioactive Fraction (Hidelsa®) |
| Jenis Penelitian | Interventional |
| Intervensi | The product to be investigated is Forhidrol bioactive fraction 500 mg caplet (Hidelsa®) |
| Jumlah Subyek Penelitian | 80 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Signed informed consent from the subject or subject’s legally acceptable representatives (must be obtained before any trial related activities), Male or female subjects with age of 18-55 years at screening, Total cholesterol level 150-250 mg/dL at screening, Able to take oral medicationExclusion Criteria: History of familial dyslipidemia, Subjects with LDL cholesterol level > 190 mg/dL at screening, History of or presence of diabetes mellitus disease or hypertension or cardiovascular diseases, Blood pressure more than ≥140 mmHg for systolic blood pressure an ≥90 mmHg for diastolic blood pressure during screening, Impaired liver function with SGOT or SGPT level >2.5 x ULN at screening, Impaired renal function with e-GFR < 60 mL/min, Pregnant woman or breastfeeding woman (urine HCG test will be applied), Known or suspected hypersensitivity to the trial product or related products, Participation in any other clinical studies within 30 days prior to screening, No other routine medication |
| Administrative Information | |
| Nomor Persetujuan Etik | UM.01.05/2.2.2/053/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |