Randomized Controlled Clinical Trial to Evaluate The Efficacy and Safety of Healthtone as Prophylaxis for COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Dietary Supplement: Rhea® Health Tone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active (Investigational Product)<br>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 | Dietary Supplement: Rhea® Health Tone<br>* Rhea® Health Tone<br>|
| Placebo Comparator: Placebo (Control Product)<br>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 | Dietary Supplement: Rhea® Health Tone<br>* Rhea® Health Tone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthtone, Prophylaxis COVID-19