The Effects of Acupuncture in Overcoming Inflammatory Response to COVID-19 Mild-moderate Symptoms
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|ClinicalTrials.gov Identifier: NCT04844710|
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Acupuncture Covid19||Combination Product: acupuncture and standard care Drug: standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 1, 2020|
|Actual Primary Completion Date :||November 15, 2020|
|Actual Study Completion Date :||November 20, 2020|
Manual acupuncture and standard care
Combination Product: acupuncture and standard care
manual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care
Other Name: Combined Treatment of Acupuncture Intervention and Standard of Care
Standard care only
Drug: standard care
standard care only
Other Name: standard of care COVID-19
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844710
|Medical Acupuncture Department FKUI-RSCM|
|Jakarta, Indonesia, 10430|
|Principal Investigator:||Dwi Rachma Helianthi, MD||Indonesia University|