Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts ( NW Roselle): A phase‐II , randomized, double‐blind, captopril‐controlled clinical trial

2020 ◽  
Vol 34 (12) ◽  
pp. 3379-3387
Author(s):  
Nabil Elkafrawy ◽  
Khaled Younes ◽  
Ahmed Naguib ◽  
Hytham Badr ◽  
Shimaa Zewain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medicinal Product ◽  
Phase Ii ◽  
Antihypertensive Efficacy ◽  
Controlled Clinical Trial ◽  
Hibiscus Sabdariffa ◽  
Efficacy And Safety ◽  
Herbal Medicinal Product ◽  
Double Blind ◽  
Herbal Medicinal

Clinical Effects Produced by a Standardized Herbal Medicinal Product of Hibiscus sabdariffa on Patients with Hypertension. A Randomized, Double-blind, Lisinopril-Controlled Clinical Trial

Planta Medica ◽  
2006 ◽  
Vol 73 (01) ◽  
pp. 6-12 ◽  
Author(s):  
Armando Herrera-Arellano ◽  
Judith Miranda-Sánchez ◽  
Pedro Ávila-Castro ◽  
Sara Herrera-Álvarez ◽  
Jesús Jiménez-Ferrer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medicinal Product ◽  
Controlled Clinical Trial ◽  
Clinical Effects ◽  
Hibiscus Sabdariffa ◽  
Herbal Medicinal Product ◽  
Double Blind ◽  
Herbal Medicinal

scholarly journals Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial

Spinal Cord ◽  
2011 ◽  
Vol 50 (2) ◽  
pp. 141-146 ◽  
Author(s):  
M L Yang ◽  
J J Li ◽  
K F So ◽  
J Y H Chen ◽  
W S Cheng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injuries ◽  
Lithium Carbonate ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Lithium Carbonate Treatment

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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