COVID-19 Clinical Trial
Official title:
Randomized Controlled Clinical Trial to Evaluate The Efficacy and Safety of Healthtone as Prophylaxis for COVID-19 in Human Resources at Persahabatan Central General Hospital
Verified date | April 2022 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background : Coronavirus disease known as COVID-19 is caused by the SARS-CoV-2. Transmission of SARS CoV-2 is spreading from human to human through direct or indirect droplets, this disease then spreads very quickly to various countries until it becomes a pandemic. Rhea® Health Tone is an essential oil made from Gardenia jasminoides, Commiphora myrrha, Boswellia serrata, Daucus carota, Foeniculum vulgarae, and Olea Europeae that have antimicrobial and anti-inflammatory effects. Rhea® Health Tone also has been registed on BPOM. Even so, the efficacy of Rhea® Health Tone still needs to be studied further. This research aimed to assess the efficacy and safety of healthtone as prophylaxis for COVID-19 in human resources at persahabatan central general hospital.The intervention group received Rhea® Health Tone 2 times supplementation 1 ml a day; meanwhile, the control group received placebo 2 times supplementation 1 ml a day.
Status | Completed |
Enrollment | 92 |
Est. completion date | March 17, 2022 |
Est. primary completion date | March 17, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18-65 years old - Human resources in persahabatan central general hospital while being a research subject - Wear PPE according to their respective work standards. - Not previously infected with COVID-19, or have been infected with COVID-19 19 previously with non-reactive IgG serological results. - Have not received a COVID-19 vaccine or have received 2nd dose of vaccine COVID-19 but manifest non-reactive IgG serological results - Subject voluntarily gave written consent to participate in this research. Exclusion Criteria: - Patients with severe comorbid factors such as: uncontrolled congestive heart disease, renal insufficiency, coronary heart disease, chronic liver disease, diabetes mellitus with complications, uncontrolled hypertension or crisis hypertension, immunocompromised, CNS disorders (such as stroke, epilepsy, Alzheimer's, meningitis) , cancer, HIV, AIDS. - Subjects who are pregnant or breastfeeding. - Subjects who cannot be included in the study according to consideration of the researcher. - Subjects who are in the process of taking other drug clinical trials. - Subjects with a history of allergy to the components of the test drug. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of confirmed COVID-19 subjects from the results of PCR | The incidence of confirmed COVID-19 subjects from the results of PCR nasopharyngeal swab examination in 96 days of trial period from nasopharyngeal swab sample | 96 days of trial period | |
Secondary | Clinical changes based on history | Clinical changes in subjects based on history | 96 days of trial period | |
Secondary | Clinical changes based on Physical examination | Nutritional status weight in kilograms, height in meters and will be combined to report BMI in kg/m^2, physical examination from of a generalist status examination, thorax examination, gastrointestinal examination. | 96 days of trial period | |
Secondary | Change in parameter Hb | Hb (g/dl) | Second day of screening and evaluation day 84 | |
Secondary | Change in parameter Ht | Ht (%) | Second day of screening and evaluation day 84 | |
Secondary | Change in parameter Leukocytes | Leukocytes (µL) | Second day of screening and evaluation day 84 | |
Secondary | Change in parameter diff count | Diff count (%) | Second day of screening and evaluation day 84 | |
Secondary | Change in parameter ESR | ESR (mm) | Second day of screening and evaluation day 84 | |
Secondary | Change in parameter Platelets | Platelets (µL) | Second day of screening and evaluation day 84 | |
Secondary | Inflammatory markers | IL-10 (pg/mL) | Second day of screening and evaluation day 84 | |
Secondary | Kidney Function Creatinine | Creatinine (mg/dL) | Second day of screening and evaluation day 84 | |
Secondary | Kidney Function | Urea (U/L) | Second day of screening and evaluation day 84 | |
Secondary | Liver function | ALT (U/L) | Second day of screening and evaluation day 84 | |
Secondary | Liver function AST | AST (U/L) | Second day of screening and evaluation day 84 | |
Secondary | Liver function Bilirubin | Bilirubin (mg/dL) | Second day of screening and evaluation day 84 | |
Secondary | ECG examination | ECG rhythm changes | Second day of screening and evaluation day 84 | |
Secondary | Blood clotting | aPTT (second), PT (second) | Second day of screening and evaluation day 84 | |
Secondary | Examination of feces | Fecal occult blood test for gastrointestinal tract | Second day of screening and evaluation day 84 | |
Secondary | The number with Rhea HealthTone related adverse events | Symptoms of adverse events with Rhea Health Tone related including those that are serious or life-threatening that occurred during the study | 96 days of trial period |
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