Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes of inflammatory cells and marker
研究概览
简要总结
This study was an experimental, randomized clinical trial, with a parallel design, with aims were seeing the effectiveness of extracted Psidii guava on white blood cells (WBCs) count, neutrophil, lymphocyte, monocyte, neutrophil-lymphocyte ratio (NLR), high sensitive C reactive protein (hs-CRP), proportion and duration COVID-19 seroconversion subjects compared to controls.
One of the herbs standardized that was commonly used in Indonesia is extracted Psidii guava, which is known as a guava leaf extract. Extract Psidii guava contains chemical substances saponins, oleanolic acid, xylopyranoside, flavonoids, quercetin, arabinopyranoside, and Guaijavarin. The Previous study on Psidii guava stated that guava leaves contain lots of flavonoids, especially quercetin. An in vitro study of dengue virus type 2 found that quercetin significantly inhibited the activity of the DEN-2 virus, while other flavonoids looked weaker. On the other hand, in an in vitro test of glycosylated flavonoids from Psidium Geunesse, which is a guava leaf from Brazil, received the use of flavonoids in Psidium Geunesse to inhibit HIV-1 virus activity with a 50% inhibition concentration of about 8.5 μg / ml compared to single active substances. Quercetin with a 50% inhibitory concentration of about 53μg / ml. These flavonoids also inhibited the enzyme reverse transcriptase HIV-1(RT)with an inhibition concentration of 7.2 μM compared to quercetin 0.6 μM single. Another study found that quercetin in Psidii guava inhibits RNA polymerase, which is important in dengue virus replication. In addition, quercetin can inhibit protease enzyme, helicase domain, and viral ATPase enzyme.
There is an antiviral effect based on limited in vitro studies but with quite a lot of literature studies, and considering that there are no effective antiviral drugs against COVID-19, especially mild and moderate cases, also considering the length of healing time for patients COVID-19 with the risk of isolation. For a long time with various consequences, researchers tried to examine the effectiveness of extract Psidii guava inpatients COVID-19 at the quarantine location of the West Sumatra Provincial Government. Extract Psidii guava is hypothesized to improve WBCs, neutrophil, lymphocyte, monocyte, NLR, hs-CRP level, to increase proportion and shorten the duration of COVID-19 seroconversion in mild and symptomless cases.
详细描述
There will be 2 groups of treatment; each group will consist of 45 subjects with the treatment regimens maximal for 4 weeks.
The treatment I: 2 capsules of Extract Psidii guava, three times daily. Treatment II: standard therapy for Covid-19 patient (vitamin C, Zink, medication for clinical symptoms such as antipyretic agent, decongestant, and mucolytic).
The eligible subjects will be randomly allocated to receive study medication (Treatment 1 or Treatment 2) for 7 days, if the result swab after treatment still positive, patients will be given extract Psidii guava capsule with the same dose till maximal 4 weeks. Treatment Group 1 will receive 2 capsules of Extract Psidii guava, three times daily. While Treatment Group 2 will receive the standard therapy for Covid-19 patient.
Subjects will be evaluated for treatment efficacy at baseline 7 days after treatment and 28 days (4 weeks) treatment. The demographic profile, such as age and sex, will be measured at baseline. White blood cells count, neutrophil, lymphocyte, monocyte, NLR, hs-CRP level at baseline and 7 days after treatment, while proportion and duration COVID-19 seroconversion will be measured.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Confirmed positive COVID-19 mild and symptomless
- •Aged 13 - 59 years
- •Willing to take part in the study and sign an informed consent
排除标准
- •Not willing to join the study
- •History of allergy to the research drug (extract Psidii guava)
研究组 & 干预措施
Extract Psidii guava
2 Capsule of extract Psidii guava, three times daily
干预措施: Extract Psidii guava (Drug)
Extract Psidii guava
2 Capsule of extract Psidii guava, three times daily
干预措施: Standard therapy for Covid-19 patient (Combination Product)
Standard therapy
Standard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
干预措施: Standard therapy for Covid-19 patient (Combination Product)
结局指标
主要结局
Changes of inflammatory cells and marker
时间窗: 7 days (1 week)
1. Leucocyte count in mm3 2. Neutrophil count in % 3. Lymphocyte count in % 4. Monocyte count in % 5. Neutrophil-lymphocyte ratio 6. High sensitivity C reactive protein in ng/mL
次要结局
- Recovery rate(14 days (2 weeks), maximal 28 days (4 weeks))
- Duration of seroconversion(Maximal 28 days)
研究者
Fredia Heppy, MD, SpPD, FINASIM
Lecturer of Internal Medicine, Prinsipal Investigator
Faculty of Medicine Baiturrahmah University