COVID-19NCT05308615
Randomized Controlled Clinical Trial to Evaluate The Efficacy and Safety of Healthtone as Prophylaxis for COVID-19
A study testing Rhea® Health Tone in people with COVID-19, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Rhea® Health Tone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Mar 2021to 17 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Rhea® Health Tone
- Keywords
- Healthtone, Prophylaxis COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhea® Health ToneDietary supplement
Rhea® Health Tone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Rhea® Health Tone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 96 days of trial period
Secondary outcomes (18)
Clinical changes based on history
Clinical changes in subjects based on history
Measured: 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.
Measured: 96 days of trial period
Change in parameter Hb
Hb (g/dl)
Measured: Second day of screening and evaluation day 84
Change in parameter Ht
Ht (%)
Measured: Second day of screening and evaluation day 84
Change in parameter Leukocytes
Leukocytes (µL)
Measured: Second day of screening and evaluation day 84
Change in parameter diff count
Diff count (%)
Measured: Second day of screening and evaluation day 84
Change in parameter ESR
ESR (mm)
Measured: Second day of screening and evaluation day 84
Change in parameter Platelets
Platelets (µL)
Measured: Second day of screening and evaluation day 84
Inflammatory markers
IL-10 (pg/mL)
Measured: Second day of screening and evaluation day 84
Kidney Function Creatinine
Creatinine (mg/dL)
Measured: Second day of screening and evaluation day 84
Kidney Function
Urea (U/L)
Measured: Second day of screening and evaluation day 84
Liver function
ALT (U/L)
Measured: Second day of screening and evaluation day 84
Liver function AST
AST (U/L)
Measured: Second day of screening and evaluation day 84
Liver function Bilirubin
Bilirubin (mg/dL)
Measured: Second day of screening and evaluation day 84
ECG examination
ECG rhythm changes
Measured: Second day of screening and evaluation day 84
Blood clotting
aPTT (second), PT (second)
Measured: Second day of screening and evaluation day 84
Examination of feces
Fecal occult blood test for gastrointestinal tract
Measured: 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
Measured: 96 days of trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start3 Mar 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erlina Burhan, Universitas Indonesia
- Investigators
- Erlina Burhan, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308615
- Sponsor's protocol ID
- 60.A.4/KEPK/RSUPP/O7/2021
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05308615
- Acronym / sponsor ID
- 60.A.4/KEPK/RSUPP/O7/2021
- Conditions
- COVID-19
- Keywords
- Healthtone, Prophylaxis COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active (Investigational Product) | Experimental | Dietary Supplement: Rhea® Health ToneInvestigational (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) | Placebo comparator | Dietary Supplement: Rhea® Health TonePlacebo (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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhea® Health ToneRhea® Health Tone | Dietary supplement | Active (Investigational Product), Placebo (Control Product) |
Primary outcome
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
18 secondary outcomes
Clinical changes based on history
Time frame: 96 days of trial period
Clinical changes based on Physical examination
Time frame: 96 days of trial period
Change in parameter Hb
Time frame: Second day of screening and evaluation day 84
Change in parameter Ht
Time frame: Second day of screening and evaluation day 84
Change in parameter Leukocytes
Time frame: Second day of screening and evaluation day 84
Change in parameter diff count
Time frame: Second day of screening and evaluation day 84
Change in parameter ESR
Time frame: Second day of screening and evaluation day 84
Change in parameter Platelets
Time frame: Second day of screening and evaluation day 84
Inflammatory markers
Time frame: Second day of screening and evaluation day 84
Kidney Function Creatinine
Time frame: Second day of screening and evaluation day 84
Kidney Function
Time frame: Second day of screening and evaluation day 84
Liver function
Time frame: Second day of screening and evaluation day 84
Liver function AST
Time frame: Second day of screening and evaluation day 84
Liver function Bilirubin
Time frame: Second day of screening and evaluation day 84
ECG examination
Time frame: Second day of screening and evaluation day 84
Blood clotting
Time frame: Second day of screening and evaluation day 84
Examination of feces
Time frame: Second day of screening and evaluation day 84
The number with Rhea HealthTone related adverse events
Time frame: 96 days of trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Related trials for COVID-19
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erlina Burhan, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhea® Health Tone in people with COVID-19, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of confirmed COVID-19 subjects from the results of PCR (time frame: 96 days of trial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.