A Randomized, Double-blinded, Double-dummy, Positive-controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract in Patients with Stage-1 Hypertension
Tahapan Penelitian : Complete
Sponsor:
Institut Teknologi Bandung
Mitra Pelaksana:
PT Equilab International
No Registry
INA-7O88WOGQ
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-01-2024 |
| Outcome Primer | Change of blood pressure after 12 weeks of combination extract antihypertension treatment in absolute and percentage value compared to standard therapy Amlodipine. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A Randomized, Double-blinded, Double-dummy, Positive-controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract in Patients with Stage-1 Hypertension |
| Judul Penelitian Ilmiah | A Randomized, Double-blinded, Double-dummy, Positive-controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract in Patients with Stage-1 Hypertension |
| Jenis Penelitian | Interventional |
| Intervensi | The product to be investigated is leaves extract of combination herbal A. cordifolia and S. arvensis. Each capsule contains 280 mg leaves extract A. cordifolia and 280 mg leaves extract S. arvensis. |
| Jumlah Subyek Penelitian | 126 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study, Male and female subject aged 20 – 50 years with essential hypertensive inclusive, which is not the result of a medical condition with SBP 140-159 and/or DBP 90-99 mmHg in a seated position, Patients who are not in ongoing any hypertension treatment at least 8 weeks, Vital signs (after 10 minutes rest) must be within systolic blood pressure of 140-159 mmHg and diastolic blood pressure of 90-99 mmHgExclusion Criteria: History/known of hypersensitivity to Amlodipine or allied drug or the content of the study drug, Patients with history of diabetes mellitus, hepatic disease, malignancy, heart disease (CHF, MI), eGFR calculation < 60, Moderate or heavy smoker calculated by Brinkman Index, History of consume alcohol within 6 months prior to screening, Pregnant or breastfeeding woman, Participating in any clinical trial within 90 days prior to study screening, Any other known current medical condition, which, is judged by the investigator could jeopardize subject’s health or interfere with the study evaluation |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1025/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |