Clinical trial NCT06636760: Efficacy and Immunomodulator Impact of Herbal Combination on COVID-19 Patients Recovery
Official title: Efficacy and Safety of Herbal Combination As Adjuvant Therapy for Mild and Moderate COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID 19
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* The RCT included patients who met the following criteria: \&amp;amp;gt;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).

Exclusion Criteria:

* Patients were excluded if they had any of the following conditions: an oxygen saturation of less than 93%, participating in other clinical trials, pregnant or lactating, receiving other immunomodulatory drugs, had a history of allergies to the test product, or the history of tuberculosis, HIV/AIDS, psychosis, or autoimmune disorders. Subjects may also be dropped from the clinical trial if they withdraw, fail to comply with the protocol (including using less than 80% of the test product), disappear, or no longer meet the inclusion criteria. Adverse events, worsening conditions, or new diagnoses during the trial also warrant exclusion.

Primary outcomes:
measure: Number of days required to improve clinical symptoms
timeFrame: 14 days
measure: Improvement of WHO ordinal scale
timeFrame: 14 days
measure: The EQ-5D-5L Quality of Life Measure
timeFrame: 14 days
measure: Number of days required for respiratory rate to return to normal
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: The National Emergency Hospital for COVID-19, Wisma Atlet
state: DKI Jakarta
Study officials:
References: