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

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Rhea® Health Tone

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Healthtone, Prophylaxis COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active (Investigational Product)

Placebo (Control Product)

Arm Description

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): 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical changes based on history

Clinical changes in subjects based on history

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.

Change in parameter Hb

Hb (g/dl)

Change in parameter Ht

Ht (%)

Change in parameter Leukocytes

Leukocytes (µL)

Change in parameter diff count

Diff count (%)

Change in parameter ESR

ESR (mm)

Change in parameter Platelets

Platelets (µL)

Inflammatory markers

IL-10 (pg/mL)

Kidney Function Creatinine

Creatinine (mg/dL)

Kidney Function

Urea (U/L)

Liver function

ALT (U/L)

Liver function AST

AST (U/L)

Liver function Bilirubin

Bilirubin (mg/dL)

ECG examination

ECG rhythm changes

Blood clotting

aPTT (second), PT (second)

Examination of feces

Fecal occult blood test for gastrointestinal tract

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

Full Information

NCT ID

NCT05308615

First Posted

March 23, 2022

Last Updated

April 25, 2022

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT05308615

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

March 3, 2021 (Actual)

Primary Completion Date

March 17, 2022 (Actual)

Study Completion Date

March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Healthtone, Prophylaxis COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active (Investigational Product)

Arm Type

Experimental

Arm Description

Arm Title

Placebo (Control Product)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Rhea® Health Tone

Intervention Description

Rhea® Health Tone

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

96 days of trial period

Secondary Outcome Measure Information:

Title

Clinical changes based on history

Description

Clinical changes in subjects based on history

Time Frame

96 days of trial period

Title

Clinical changes based on Physical examination

Description

Time Frame

96 days of trial period

Title

Change in parameter Hb

Description

Hb (g/dl)

Time Frame