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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: Rhea® Health Tone

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active (Investigational Product); 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; Rhea® Health Tone
PLACEBO_COMPARATOR: Placebo (Control Product); 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; Rhea® Health Tone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Erlina Burhan, MD, PhD, Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2021
• Primary Completion (ACTUAL): March 17, 2022
• Study Completion (ACTUAL): March 17, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (ACTUAL): April 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Prophylaxis COVID-19; Healthtone
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 60.A.4/KEPK/RSUPP/O7/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No