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OpenTrials
Completed

NCT Number: NCT04844710

The Effects of Acupuncture in Overcoming Inflammatory Response to COVID-19 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.

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.

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Key information

Conditions

Acupuncture COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Acupuncture Department FKUI-RSCM

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

acupuncture and standard care

Combination Product

manual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care

Other names: Combined Treatment of Acupuncture Intervention and Standard of Care

Standard care

Drug

standard care only

Other names: standard of care COVID-19

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Clinical changes

    Time frame: before treatment and after 2 weeks of treatment

    duration of cough and fever during the patients are hospitalized

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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