A Randomized, Double-blinded, Placebo-Controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract as Adjunctive Treatment in Patients with moderate Hypertension
Tahapan Penelitian : Complete
Sponsor:
Institut Teknologi Bandung
Mitra Pelaksana:
PT. Equilab International
No Registry
INA-8FG5Z0XE
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 02-11-2021 |
| Outcome Primer | To evaluate efficacy of combination Anredera cordifolia and Sonchus arvensis leaves extract as adjunctive therapy in patients with moderate hypertension. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A Randomized, Double-blinded, Placebo-Controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract as Adjunctive Treatment in Patients with moderate Hypertension |
| Judul Penelitian Ilmiah | A Randomized, Double-blinded, Placebo-Controlled Clinical Study to Evaluate Antihypertension Effect of Combination Anredera cordifolia and Sonchus arvensis Leaves Extract as Adjunctive Treatment in Patients with moderate Hypertension |
| Jenis Penelitian | Interventional |
| Intervensi | Each capsule contains 280 mg leaves extract A. cordifolia and 280 mg leaves extract S. arvensis |
| Jumlah Subyek Penelitian | 60 |
| 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 subjects aged 20-60 years inclusive, 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 or known of hypersensitivity to Amlodipin or allied drug or the content of the study drug, subjects who are not in ongoing any hypertension treatment at least 21 days, patients with SBP >160 mmHg, patients with history of diabetes mellitus, hepatic disease, malignancy, heart disease (CHF, MI), smoker >10 cigarettes per day, history of consume alcohol within 6 months prior to screening, pregnant or breastfeeding woman, positive result for COVID-19 rapid antigen test, 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 study evaluation |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-865-UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |