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NCT Number: NCT05308615

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rhea® Health Tone

Dietary Supplement

Rhea® Health Tone

Primary outcomes

  1. The incidence of confirmed COVID-19 subjects from the results of PCR

    Time frame: 96 days of trial period

    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

Secondary outcomes

  1. Clinical changes based on history

    Time frame: 96 days of trial period

    Clinical changes in subjects based on history

  2. Clinical changes based on Physical examination

    Time frame: 96 days of trial period

    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.

  3. Change in parameter Hb

    Time frame: Second day of screening and evaluation day 84

    Hb (g/dl)

  4. Change in parameter Ht

    Time frame: Second day of screening and evaluation day 84

    Ht (%)

  5. Change in parameter Leukocytes

    Time frame: Second day of screening and evaluation day 84

    Leukocytes (µL)

  6. Change in parameter diff count

    Time frame: Second day of screening and evaluation day 84

    Diff count (%)

  7. Change in parameter ESR

    Time frame: Second day of screening and evaluation day 84

    ESR (mm)

  8. Change in parameter Platelets

    Time frame: Second day of screening and evaluation day 84

    Platelets (µL)

  9. Inflammatory markers

    Time frame: Second day of screening and evaluation day 84

    IL-10 (pg/mL)

  10. Kidney Function Creatinine

    Time frame: Second day of screening and evaluation day 84

    Creatinine (mg/dL)

  11. Kidney Function

    Time frame: Second day of screening and evaluation day 84

    Urea (U/L)

  12. Liver function

    Time frame: Second day of screening and evaluation day 84

    ALT (U/L)

  13. Liver function AST

    Time frame: Second day of screening and evaluation day 84

    AST (U/L)

  14. Liver function Bilirubin

    Time frame: Second day of screening and evaluation day 84

    Bilirubin (mg/dL)

  15. ECG examination

    Time frame: Second day of screening and evaluation day 84

    ECG rhythm changes

  16. Blood clotting

    Time frame: Second day of screening and evaluation day 84

    aPTT (second), PT (second)

  17. Examination of feces

    Time frame: Second day of screening and evaluation day 84

    Fecal occult blood test for gastrointestinal tract

  18. The number with Rhea HealthTone related adverse events

    Time frame: 96 days of trial period

    Symptoms of adverse events with Rhea Health Tone related including those that are serious or life-threatening that occurred during the study

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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