COVID 19NCT06636760
Efficacy and Immunomodulator Impact of Herbal Combination on COVID-19 Patients Recovery
A study testing herbal compound in people with COVID 19, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to evaluate the efficacy and safety of Herbamuno+, a combination of several herbal ingredients, as an adjunct therapy for moderate COVID-19 patients at Wisma Atlet. The study involves 66 patients who were divided into two groups: one receiving Herbamuno+ and the other a placebo, both for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID 19
- What is being tested?
- herbal compound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Aug 2021to 28 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The RCT included patients who met the following criteria: \>18 years old, had recently tested positive for COVID-19 through RT-PCR within the past five days, and were categorized as moderate cases. The main clinical symptoms required for inclusion were acute fever (greater than 38 °C) and cough, or more than three of the following acute symptoms or signs: fever, cough, fatigue, headache, muscle pain, sore throat, nasal congestion, runny nose, shortness of breath, anorexia, nausea, vomiting, diarrhea, anosmia, or ageusia. The moderate case criteria are based on WHO criteria including the radiology imaging that indicating pneumonia (new infiltrates to consolidation) and clinical signs of pneumonia (fever, cough, shortness of breath, and respiratory frequency between 20 to 30 times per minute).
Who cannot join
- Patients were excluded if they had any of the following conditions: an oxygen saturation of less than 93%, participating in other clinical trials, pregnant or lactating, receiving other immunomodulatory drugs, had a history of allergies to the test product, or the history of tuberculosis, HIV/AIDS, psychosis, or autoimmune disorders. Subjects may also be dropped from the clinical trial if they withdraw, fail to comply with the protocol (including using less than 80% of the test product), disappear, or no longer meet the inclusion criteria. Adverse events, worsening conditions, or new diagnoses during the trial also warrant exclusion.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
The National Emergency Hospital for COVID-19, Wisma Atlet
Jakarta, DKI Jakarta, 14360
About this study
Official title: Efficacy and Safety of Herbal Combination As Adjuvant Therapy for Mild and Moderate COVID-19 Patients
This study aims to evaluate the efficacy and safety of Herbamuno+, a combination of several herbal ingredients, as an adjunct therapy for moderate COVID-19 patients at Wisma Atlet. The study involves 66 patients who were divided into two groups: one receiving Herbamuno+ and the other a placebo, both for 14 days. Researchers monitored clinical improvements, chest X-rays, and blood tests to assess inflammation and immune response. The goal is to determine whether Herbamuno+ can be safely and effectively added to standard COVID-19 treatment.
- Conditions
- COVID 19
- Being tested
- Placebo, herbal compound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
The placebo contains the non-active carrier of herbal combination that has no pharmacological activity.
herbal compoundDietary supplement
The herbal combination is made up of various medicinal plants and possesses immunomodulator properties. It comprises Phyllanthus niruri, Andrographis paniculata, and Glycyrrhiza glabra, along with Anacardium occidentale leaf and Zingiber officinale rhizome, all recognized for their immunomodulatory properties.
| Study group | Role | What they receive |
|---|---|---|
| Herbal combination; Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Herbal Combination | Active comparator | Not described Receives: Dietary Supplement: herbal compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days required to improve clinical symptoms
This outcome measures how long it takes for a patient's symptoms to improve from the time of hospital admission based on anamnesis (patient history). Anamnesis includes information such as the duration and severity of the symptoms experienced by the patient. The improvement is tracked through daily assessments, comparing the patient's initial complaints upon admission to their status over time, noting any reduction in symptoms such as fever, cough, fatigue, or difficulty breathing. The goal is to quantify the days required to see a noticeable improvement in clinical symptoms.
Measured: 14 days
Improvement of WHO ordinal scale
This outcome combines two critical assessments:
WHO Ordinal Scale: This scale typically ranges from 0 (uninfected) to 8 (death), with each level corresponding to the patient's clinical status (e.g., mild disease, severe disease requiring oxygen support, or critical illness requiring mechanical ventilation). The improvement is measured by tracking the reduction in ordinal score over time, indicating a recovery or a shift toward a less severe category.
Measured: 14 days
The EQ-5D-5L Quality of Life Measure
The EQ-5D-5L covers five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and has five response levels for each dimension, ranging from no problems to extreme problems. Improvement in this measure indicates better overall health and well-being. The EQ-5D-5L also includes a visual analog scale (VAS) where patients rate their overall health from 0 (worst possible health) to 100 (best possible health).
Measured: 14 days
Number of days required for respiratory rate to return to normal
This outcome measures how long the patient's respiratory rate stabilizes and returns to normal levels. A normal respiratory rate in adults is typically 12 to 20 breaths per minute. This measure focuses on how many days it takes for the respiratory rate to reduce to or below 20 breaths per minute (indicating improvement from conditions such as tachypnea or labored breathing). Daily monitoring is required to track this change, as an elevated respiratory rate is a common symptom of respiratory distress, infection, or severe illness.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Aug 2021
- Primary completion28 Mar 2022
- Study completion28 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Anna Rozaliyani, M.Biomed, Sp.P(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636760
- Sponsor's protocol ID
- 20-11-1403
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Herbal Combination As Adjuvant Therapy for Mild and Moderate COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06636760
- Acronym / sponsor ID
- 20-11-1403
- Conditions
- COVID 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 15 Oct 2024 (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.
This study aims to evaluate the efficacy and safety of Herbamuno+, a combination of several herbal ingredients, as an adjunct therapy for moderate COVID-19 patients at Wisma Atlet. The study involves 66 patients who were divided into two groups: one receiving Herbamuno+ and the other a placebo, both for 14 days. Researchers monitored clinical improvements, chest X-rays, and blood tests to assess inflammation and immune response. The goal is to determine whether Herbamuno+ can be safely and effectively added to standard COVID-19 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal combination; Placebo | Placebo comparator | Other: Placebo |
| Herbal Combination | Active comparator | Dietary Supplement: herbal compound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The RCT included patients who met the following criteria: \>18 years old, had recently tested positive for COVID-19 through RT-PCR within the past five days, and were categorized as moderate cases. The main clinical symptoms required for inclusion were acute fever (greater than 38 °C) and cough, or more than three of the following acute symptoms or signs: fever, cough, fatigue, headache, muscle pain, sore throat, nasal congestion, runny nose, shortness of breath, anorexia, nausea, vomiting, diarrhea, anosmia, or ageusia. The moderate case criteria are based on WHO criteria including the radiology imaging that indicating pneumonia (new infiltrates to consolidation) and clinical signs of pneumonia (fever, cough, shortness of breath, and respiratory frequency between 20 to 30 times per minute).
Key exclusion criteria (1 listed)
- Patients were excluded if they had any of the following conditions: an oxygen saturation of less than 93%, participating in other clinical trials, pregnant or lactating, receiving other immunomodulatory drugs, had a history of allergies to the test product, or the history of tuberculosis, HIV/AIDS, psychosis, or autoimmune disorders. Subjects may also be dropped from the clinical trial if they withdraw, fail to comply with the protocol (including using less than 80% of the test product), disappear, or no longer meet the inclusion criteria. Adverse events, worsening conditions, or new diagnoses during the trial also warrant exclusion.
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 |
|---|---|---|
| PlaceboThe placebo contains the non-active carrier of herbal combination that has no pharmacological activity. | Other | Herbal combination; Placebo |
| herbal compoundThe herbal combination is made up of various medicinal plants and possesses immunomodulator properties. It comprises Phyllanthus niruri, Andrographis paniculata, and Glycyrrhiza glabra, along with Anacardium occidentale leaf and Zingiber officinale rhizome, all recognized for their immunomodulatory properties. | Dietary supplement | Herbal Combination |
Primary outcome
Number of days required to improve clinical symptoms
Time frame: 14 days
This outcome measures how long it takes for a patient's symptoms to improve from the time of hospital admission based on anamnesis (patient history). Anamnesis includes information such as the duration and severity of the symptoms experienced by the patient. The improvement is tracked through daily assessments, comparing the patient's initial complaints upon admission to their status over time, noting any reduction in symptoms such as fever, cough, fatigue, or difficulty breathing. The goal is to quantify the days required to see a noticeable improvement in clinical symptoms.
Improvement of WHO ordinal scale
Time frame: 14 days
This outcome combines two critical assessments: WHO Ordinal Scale: This scale typically ranges from 0 (uninfected) to 8 (death), with each level corresponding to the patient's clinical status (e.g., mild disease, severe disease requiring oxygen support, or critical illness requiring mechanical ventilation). The improvement is measured by tracking the reduction in ordinal score over time, indicating a recovery or a shift toward a less severe category.
The EQ-5D-5L Quality of Life Measure
Time frame: 14 days
The EQ-5D-5L covers five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and has five response levels for each dimension, ranging from no problems to extreme problems. Improvement in this measure indicates better overall health and well-being. The EQ-5D-5L also includes a visual analog scale (VAS) where patients rate their overall health from 0 (worst possible health) to 100 (best possible health).
Number of days required for respiratory rate to return to normal
Time frame: 14 days
This outcome measures how long the patient's respiratory rate stabilizes and returns to normal levels. A normal respiratory rate in adults is typically 12 to 20 breaths per minute. This measure focuses on how many days it takes for the respiratory rate to reduce to or below 20 breaths per minute (indicating improvement from conditions such as tachypnea or labored breathing). Daily monitoring is required to track this change, as an elevated respiratory rate is a common symptom of respiratory distress, infection, or severe illness.
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 15 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herbal compound 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 1 inclusion and 1 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 15 Oct 2024. 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?
Number of days required to improve clinical symptoms (time frame: 14 days). The study lists 4 primary outcomes in all. 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 15 Oct 2024.