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

NCT05308615 | Completed DMC

• 1 other identifier: 60.A.4/KEPK/RSUPP/O7/2021
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Healthtone; Prophylaxis COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Clinical changes based on history

  96 days of trial period

• Clinical changes based on Physical examination

  96 days of trial period

• Change in parameter Hb

  Second day of screening and evaluation day 84

• Change in parameter Ht

  Second day of screening and evaluation day 84

• Change in parameter Leukocytes

  Second day of screening and evaluation day 84

Study Arms (2)

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

Dietary Supplement: Rhea® Health Tone

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

Dietary Supplement: Rhea® Health Tone

Interventions

Rhea® Health Tone DIETARY_SUPPLEMENT

Rhea® Health Tone

Active (Investigational Product); Placebo (Control Product)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erlina Burhan, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 4, 2022
• Study Start: March 3, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

ID (1)