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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.
This study is a double-blind randomized clinical trial on the human resources population at Persahabatan Central General Hospital, Jakarta.
Subjects who have agreed to be included in the study will undergo an initial examination and a serological examination of IgG SARS-CoV-2 to ensure that there is no adequate immunity against COVID-19 before the study begins. After confirmed that all subjects are not included in the exclusion criteria and not infected with COVID-19, randomization will be conducted to determine who gets the Rhea®️ Health Tone or a placebo.
Evaluation will be carried out until the 84th day of giving the intervention. The subject will be monitored everyday by the research team to ask whether there are symptoms experienced by the subject, both symptoms related to COVID-19 and symptoms related to side effects drugs and adverse events.
The statistical test used in this study was the Chi-square test or Fisher's exact test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active (Investigational Product) | Experimental | Investigational (Active) product: Rhea® Health Tone (1.8 mg of Gardenia jasminoides; 1.8 mg Commiphora myrrha oil; 1.8 mg Boswellia serrata oil; 1.8 mg Daucus carota oil; 1.8 mg of Foeniculum vulgarae oil and 0.99 mg of Olea europeae oil or Olive oil as a solvent.) Regimen: Subjects will receive Rhea® Health Tone 2 times supplementation 1 ml a day for 84 days |
|
| Placebo (Control Product) | Placebo Comparator | Placebo (Control Product): Using olive oil without the active ingredients contained in the Rhea® Health Tone test product. Regimen: Subjects will receive Placebo 2 times supplementation 1 ml a day for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhea® Health Tone | Dietary Supplement | Rhea® Health Tone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical changes based on history | Clinical changes in subjects based on history | 96 days of trial period |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erlina Burhan, MD, PhD | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 96 days of trial period |
| Change in parameter Hb | Hb (g/dl) | Second day of screening and evaluation day 84 |
| Change in parameter Ht | Ht (%) | Second day of screening and evaluation day 84 |
| Change in parameter Leukocytes | Leukocytes (µL) | Second day of screening and evaluation day 84 |
| Change in parameter diff count | Diff count (%) | Second day of screening and evaluation day 84 |
| Change in parameter ESR | ESR (mm) | Second day of screening and evaluation day 84 |
| Change in parameter Platelets | Platelets (µL) | Second day of screening and evaluation day 84 |
| Inflammatory markers | IL-10 (pg/mL) | Second day of screening and evaluation day 84 |
| Kidney Function Creatinine | Creatinine (mg/dL) | Second day of screening and evaluation day 84 |
| Kidney Function | Urea (U/L) | Second day of screening and evaluation day 84 |
| Liver function | ALT (U/L) | Second day of screening and evaluation day 84 |
| Liver function AST | AST (U/L) | Second day of screening and evaluation day 84 |
| Liver function Bilirubin | Bilirubin (mg/dL) | Second day of screening and evaluation day 84 |
| ECG examination | ECG rhythm changes | Second day of screening and evaluation day 84 |
| Blood clotting | aPTT (second), PT (second) | Second day of screening and evaluation day 84 |
| Examination of feces | Fecal occult blood test for gastrointestinal tract | Second day of screening and evaluation day 84 |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |