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

NCT06636760 | Completed

• 1 other identifier: 20-11-1403
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (4)

• Number of days required to improve clinical symptoms

  This outcome measures how long it takes for a patient's symptoms to improve from the time of hospital admission based on anamnesis (patient history). Anamnesis includes information such as the duration and severity of the symptoms experienced by the patient. The improvement is tracked through daily assessments, comparing the patient's initial complaints upon admission to their status over time, noting any reduction in symptoms such as fever, cough, fatigue, or difficulty breathing. The goal is to quantify the days required to see a noticeable improvement in clinical symptoms.

  14 days

• Improvement of WHO ordinal scale

  This outcome combines two critical assessments: WHO Ordinal Scale: This scale typically ranges from 0 (uninfected) to 8 (death), with each level corresponding to the patient's clinical status (e.g., mild disease, severe disease requiring oxygen support, or critical illness requiring mechanical ventilation). The improvement is measured by tracking the reduction in ordinal score over time, indicating a recovery or a shift toward a less severe category.

  14 days

• The EQ-5D-5L Quality of Life Measure

  The EQ-5D-5L covers five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and has five response levels for each dimension, ranging from no problems to extreme problems. Improvement in this measure indicates better overall health and well-being. The EQ-5D-5L also includes a visual analog scale (VAS) where patients rate their overall health from 0 (worst possible health) to 100 (best possible health).

  14 days

• Number of days required for respiratory rate to return to normal

  This outcome measures how long the patient's respiratory rate stabilizes and returns to normal levels. A normal respiratory rate in adults is typically 12 to 20 breaths per minute. This measure focuses on how many days it takes for the respiratory rate to reduce to or below 20 breaths per minute (indicating improvement from conditions such as tachypnea or labored breathing). Daily monitoring is required to track this change, as an elevated respiratory rate is a common symptom of respiratory distress, infection, or severe illness.

  14 days

Study Arms (2)

Herbal combination; Placebo

PLACEBO COMPARATOR

Other: Placebo

Herbal Combination

ACTIVE COMPARATOR

Dietary Supplement: herbal compound

Interventions

Placebo OTHER

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

Herbal combination; Placebo

herbal compound 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.

Herbal Combination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

The National Emergency Hospital for COVID-19, Wisma Atlet

Jakarta, DKI Jakarta, 14360, Indonesia

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Parasitology, Faculty of Medicine, Universitas Indonesia

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 15, 2024
• Study Start: August 27, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

ID (1)