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

NCT04844710 | Completed

• 1 other identifier: KET-845/UN2.F1/ ETIK/PPM.2020
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Covid19

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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)

  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)

  before treatment and after 2 weeks of treatment

• Clinical changes

  duration of cough and fever during the patients are hospitalized

  before treatment and after 2 weeks of treatment

Study Arms (2)

Treatment

EXPERIMENTAL

Manual acupuncture and standard care

Combination Product: acupuncture and standard care

Control

OTHER

Standard care only

Drug: standard care

Interventions

acupuncture and standard care COMBINATION_PRODUCT

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

Also known as: Combined Treatment of Acupuncture Intervention and Standard of Care

Treatment

standard care DRUG

standard care only

Also known as: standard of care COVID-19

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Medical Acupuncture Department FKUI-RSCM

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Acupuncture Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dwi Rachma Helianthi, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 14, 2021
• Study Start: September 1, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 20, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)