Efficacy and Safety of Herbal Combination As Adjuvant Therapy for Mild and Moderate COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of days required to improve clinical symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Number of days required to improve clinical symptoms
时间窗: 14 days
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.
Improvement of WHO ordinal scale
时间窗: 14 days
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.
The EQ-5D-5L Quality of Life Measure
时间窗: 14 days
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).
Number of days required for respiratory rate to return to normal
时间窗: 14 days
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.
次要结局
未报告次要终点
研究者
Dr. dr. Anna Rozaliyani, M.Biomed, Sp.P(K)
Department of Parasitology, Faculty of Medicine, Universitas Indonesia
Indonesia University