AcupunctureNCT04844710
The Effects of Acupuncture in Overcoming Inflammatory Response to COVID-19 Mild-moderate Symptoms
A study of Acupuncture and Covid19, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Coronavirus disease 2019 (COVID-19) is a problem that is being faced in more than 200 countries in the world, including Indonesia. The World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupuncture, Covid19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2020to 20 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients over 18 years of age, COVID-19 confirmed by RT-PCR with mild-moderate symptoms
- Willing to participate in research.
- Willing to follow the research process to completion.
Who cannot join
- The patient has contraindications to acupuncture (medical emergencies, pregnancy, malignancy, blood clotting disorders and consumption of anti-coagulant drugs).
- Patients with myeloproliferative disorders.
- There is a tumor or infection in the area where the acupuncture point is inserted.
- Patients with a history of uncontrolled Diabetes Mellitus with random blood sugar levels > 200 mg / dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Combined Treatment of Acupuncture Intervention & Standard of Care on Laboratory and Clinical Outcomes in Hospitalized COVID-19 Patients With Mild-Moderate Symptoms
Coronavirus disease 2019 (COVID-19) is a problem that is being faced in more than 200 countries in the world, including Indonesia. The World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic. The transmission of the virus occurred rapidly that 2 weeks from the first case diagnosed, 1000 patients tested positive. A week later, the number of positive cases exceeded 4600, reaching more than 30,000 patients and 2,500 deaths on March 18, 2020. The death rate due to COVID-19 in Indonesia is one of the highest in Asia.
To date, no therapy has been shown to be effective for Coronavirus (SARS-CoV-2). A vaccine for SARS-CoV-2 also has not been found at this time and is in the research phase. Current management of COVID-19 patients focuses primarily on providing supportive care. Currently, several countries make treatment guidelines for COVID-19 patients by providing several types of anti-viral drugs and other drugs such as chloroquine or hydroxychloroquine, immunoglobulins, anti-cytokine agents or immunomodulators.
Read more
The administration of these drugs does not escape the various side effects experienced by patients. Administration of chloroquine or hydroxychloroquine carries the risk of causing prolonged QT interval which can lead to arrhytmia disturbances such as torsades des pointes in certain people. Administration of chloroquine or hydroxychloroquine in combination with azithromycin increases the risk of developing arrhythmias. Giving anti-viruses such as lopinavir / ritonavir, umifenovir, remdesivir, favipiravir can also cause various side effects including gastrointestinal disturbances (nausea, vomiting, diarrhea), impaired liver function, and hyperuricaemia. Treatment with human immunoglobulins has been associated with a significantly increased risk of thrombotic events.
Currently, no acupuncture research on COVID-19 patients has been published. However, acupuncture can play a role in several conditions that occur in COVID-19 according to the pathophysiology that occurs, this has been proven through several clinical studies conducted on non-COVID-19 cases that have pathophysiology that resemble COVID-19 conditions. In COVID-19 with mild-moderate symptoms, acupuncture can play a role in boosting the immune system, including increasing the number of Natural Killer cells and lymphocytes. Whereas in cases of severe COVID-19 symptoms, it is hoped that acupuncture can provide anti-inflammatory effect and prevent cytokine storm.
- Conditions
- Acupuncture, Covid19
- Being tested
- acupuncture and standard care, standard care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and standard careCombination product
Also called Combined Treatment of Acupuncture Intervention and Standard of Care
manual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care
standard careDrug
Also called standard of care COVID-19
standard care only
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Manual acupuncture and standard care Receives: Combination Product: acupuncture and standard care |
| Control | Other | Standard care only Receives: Drug: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of percentage of lymphocyte count
Changes of percentage of lymphocyte count (diff count) between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Measured: before treatment and after 2 weeks of treatment
Changes of Erythrocyte sedimentation rate
Changes of Erythrocyte sedimentation rate between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Measured: before treatment and after 2 weeks of treatment
Changes of Ferritin level
Changes of Ferritin level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Measured: before treatment and after 2 weeks of treatment
Changes of C-Reactive Protein level
Changes of C-reactive protein level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Measured: before treatment and after 2 weeks of treatment
Clinical changes
duration of cough and fever during the patients are hospitalized
Measured: before treatment and after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Sep 2020
- Primary completion15 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Dwi Rachma Helianthi, Sp.Ak, Universitas Indonesia
- Investigators
- Dwi Rachma Helianthi, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844710
- Sponsor's protocol ID
- KET-845/UN2.F1/ ETIK/PPM.2020
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Treatment of Acupuncture Intervention & Standard of Care on Laboratory and Clinical Outcomes in Hospitalized COVID-19 Patients With Mild-Moderate Symptoms
- ClinicalTrials.gov ID
- NCT04844710
- Acronym / sponsor ID
- KET-845/UN2.F1/ ETIK/PPM.2020
- Conditions
- Acupuncture, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 14 Apr 2021 (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.
Coronavirus disease 2019 (COVID-19) is a problem that is being faced in more than 200 countries in the world, including Indonesia. The World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic. The transmission of the virus occurred rapidly that 2 weeks from the first case diagnosed, 1000 patients tested positive. A week later, the number of positive cases exceeded 4600, reaching more than 30,000 patients and 2,500 deaths on March 18, 2020. The death rate due to COVID-19 in Indonesia is one of the highest in Asia.
To date, no therapy has been shown to be effective for Coronavirus (SARS-CoV-2). A vaccine for SARS-CoV-2 also has not been found at this time and is in the research phase. Current management of COVID-19 patients focuses primarily on providing supportive care. Currently, several countries make treatment guidelines for COVID-19 patients by providing several types of anti-viral drugs and other drugs such as chloroquine or hydroxychloroquine, immunoglobulins, anti-cytokine agents or immunomodulators.
The administration of these drugs does not escape the various side effects experienced by patients. Administration of chloroquine or hydroxychloroquine carries the risk of causing prolonged QT interval which can lead to arrhytmia disturbances such as torsades des pointes in certain people. Administration of chloroquine or hydroxychloroquine in combination with azithromycin increases the risk of developing arrhythmias. Giving anti-viruses such as lopinavir / ritonavir, umifenovir, remdesivir, favipiravir can also cause various side effects including gastrointestinal disturbances (nausea, vomiting, diarrhea), impaired liver function, and hyperuricaemia. Treatment with human immunoglobulins has been associated with a significantly increased risk of thrombotic events.
Currently, no acupuncture research on COVID-19 patients has been published. However, acupuncture can play a role in several conditions that occur in COVID-19 according to the pathophysiology that occurs, this has been proven through several clinical studies conducted on non-COVID-19 cases that have pathophysiology that resemble COVID-19 conditions. In COVID-19 with mild-moderate symptoms, acupuncture can play a role in boosting the immune system, including increasing the number of Natural Killer cells and lymphocytes. Whereas in cases of severe COVID-19 symptoms, it is hoped that acupuncture can provide anti-inflammatory effect and prevent cytokine storm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: acupuncture and standard careManual acupuncture and standard care |
| Control | Other | Drug: standard careStandard care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients over 18 years of age, COVID-19 confirmed by RT-PCR with mild-moderate symptoms
- Willing to participate in research.
- Willing to follow the research process to completion.
Key exclusion criteria (4 listed)
- The patient has contraindications to acupuncture (medical emergencies, pregnancy, malignancy, blood clotting disorders and consumption of anti-coagulant drugs).
- Patients with myeloproliferative disorders.
- There is a tumor or infection in the area where the acupuncture point is inserted.
- Patients with a history of uncontrolled Diabetes Mellitus with random blood sugar levels > 200 mg / dL
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 |
|---|---|---|
| acupuncture and standard careAlso: Combined Treatment of Acupuncture Intervention and Standard of Caremanual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care | Combination product | Treatment |
| standard careAlso: standard of care COVID-19standard care only | Drug | Control |
Primary outcome
Changes of percentage of lymphocyte count
Time frame: before treatment and after 2 weeks of treatment
Changes of percentage of lymphocyte count (diff count) between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Changes of Erythrocyte sedimentation rate
Time frame: before treatment and after 2 weeks of treatment
Changes of Erythrocyte sedimentation rate between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Changes of Ferritin level
Time frame: before treatment and after 2 weeks of treatment
Changes of Ferritin level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Changes of C-Reactive Protein level
Time frame: before treatment and after 2 weeks of treatment
Changes of C-reactive protein level between before treatment and after 2 weeks of treatment (after sixth acupuncture session given)
Clinical changes
Time frame: before treatment and after 2 weeks of treatment
duration of cough and fever during the patients are hospitalized
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 14 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Dwi Rachma Helianthi, MD 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 of Acupuncture and Covid19, 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 3 inclusion and 4 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 14 Apr 2021. 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. 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?
Changes of percentage of lymphocyte count (time frame: before treatment and after 2 weeks of treatment). The study lists 5 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 14 Apr 2021.