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The Effects of Acupuncture in Overcoming Inflammatory Response to COVID-19 Mild-moderate Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844710
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
dr. Dwi Rachma Helianthi, Sp.Ak, Indonesia University

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
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
Control
Standard care only
 Drug: standard care
standard care only
Other Name: standard of care COVID-19


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Indonesia
Medical Acupuncture Department FKUI-RSCM
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dwi Rachma Helianthi, MD Indonesia University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: dr. Dwi Rachma Helianthi, Sp.Ak, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04844710    
Other Study ID Numbers: KET-845/UN2.F1/ ETIK/PPM.2020
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases