Efficacy and Immunomodulator Impact of Herbal Combination on COVID-19 Patients Recovery

NCT ID: NCT06636760

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2022-03-28

Brief Summary

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This study aims to evaluate the efficacy and safety of Herbamuno+, a combination of several herbal ingredients, as an adjunct therapy for moderate COVID-19 patients at Wisma Atlet. The study involves 66 patients who were divided into two groups: one receiving Herbamuno+ and the other a placebo, both for 14 days. Researchers monitored clinical improvements, chest X-rays, and blood tests to assess inflammation and immune response. The goal is to determine whether Herbamuno+ can be safely and effectively added to standard COVID-19 treatment.

Detailed Description

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Conditions

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COVID 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Herbal combination; Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The placebo contains the non-active carrier of herbal combination that has no pharmacological activity.

Herbal Combination

Group Type ACTIVE_COMPARATOR

herbal compound

Intervention Type DIETARY_SUPPLEMENT

The herbal combination is made up of various medicinal plants and possesses immunomodulator properties. It comprises Phyllanthus niruri, Andrographis paniculata, and Glycyrrhiza glabra, along with Anacardium occidentale leaf and Zingiber officinale rhizome, all recognized for their immunomodulatory properties.

Interventions

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Placebo

The placebo contains the non-active carrier of herbal combination that has no pharmacological activity.

Intervention Type OTHER

herbal compound

The herbal combination is made up of various medicinal plants and possesses immunomodulator properties. It comprises Phyllanthus niruri, Andrographis paniculata, and Glycyrrhiza glabra, along with Anacardium occidentale leaf and Zingiber officinale rhizome, all recognized for their immunomodulatory properties.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* The RCT included patients who met the following criteria: \>18 years old, had recently tested positive for COVID-19 through RT-PCR within the past five days, and were categorized as moderate cases. The main clinical symptoms required for inclusion were acute fever (greater than 38 °C) and cough, or more than three of the following acute symptoms or signs: fever, cough, fatigue, headache, muscle pain, sore throat, nasal congestion, runny nose, shortness of breath, anorexia, nausea, vomiting, diarrhea, anosmia, or ageusia. The moderate case criteria are based on WHO criteria including the radiology imaging that indicating pneumonia (new infiltrates to consolidation) and clinical signs of pneumonia (fever, cough, shortness of breath, and respiratory frequency between 20 to 30 times per minute).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dr. dr. Anna Rozaliyani, M.Biomed, Sp.P(K)

Department of Parasitology, Faculty of Medicine, Universitas Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The National Emergency Hospital for COVID-19, Wisma Atlet

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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20-11-1403

Identifier Type: -

Identifier Source: org_study_id

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