Ayurvedic Management of asymptomatic & mild symptomatic covid 19 patients - A clinical and laboratory assesment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To prevent covid19 postive cases in asymptomatic
研究概览
简要总结
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a global health crisis with a potential to produce a damage at social, economic, and political level. At present there is no approved treatment for Covid19. But the disease was highly contagious that it was transmitted to vast number of people in our country. Several studies have documented infection in patients who never developed the symptoms (Asymptomatic). Since the Asymptomatic persons are not routinely tested their prevalence to spread the infection seems to be more. Clinical laboratory finding in patients of severe Covid 19 positive suggest an immunopathology.Ayurveda mentioned about the epidemics/pandemic’s diseases under the concept of Janapadhodwamsa and infectious diseases under Sankramikaroga. Ayurvedic medicine has its own evidence in treating such infectious diseases of various causes since ages. This project is aimed to prove the efficacy of Ayurvedic management in treating the Positive Asymptomatic and mild cases of Covid19 clinically as well as in laboratory parameters.
In this study, Total 60 patients of 18-60 yrs of age, clinically diagnosed with COVID-19 by RT-PCR test who are asymptomatic or with mild symptoms were selected and randomly divided in 2 groups having 30 patients each. Group I (30 Patients) will receive Ayurveda intervention. Group II (30 Patients) will receive standard treatment for COVID-19 infection as per TN Government guidelines. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. After completion of the trial, data will be analyzed using appropriate statistical tests and the result will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •COVID-19 positive as determined by RT-PCR or other approved commercial or public health assay -Informed consent for the study -Asymptomatic stage -mild stage (cough, fever) -Respiratory rate < 24 per minute and oxygen saturation > 94%.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19 -Patients with severe COVID-19 disease defined as follows respiratory distress,oxygen saturation at rest ≤94%,severe disease complications.
- •Pregnant women or women who are breastfeeding -Immunocompromised patients taking (presently on immunosuppressant medication any time during last 90 days) -Diabetics with >9% HbA1c -Patients on antimicrobials, antibiotics, antifungals during last 30 days -Patients with active malignancy -patients with bleeding disorders -Pandu (Hb<7).
结局指标
主要结局
To prevent covid19 postive cases in asymptomatic
时间窗: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. | -Baseline | -7th day | -14th day | -21st day
and mild stages progressing into moderate and
时间窗: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. | -Baseline | -7th day | -14th day | -21st day
severe stages assessed by clinical and laboratory
时间窗: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. | -Baseline | -7th day | -14th day | -21st day
parameters and to find the time taken to
时间窗: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. | -Baseline | -7th day | -14th day | -21st day
convert SARSâ€CoVâ€2 negative determined by RT-PCR.
时间窗: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. | -Baseline | -7th day | -14th day | -21st day
次要结局
- No of cases Reporting any ADR/AE assessed clinically and by laboratory parameters(CBC,CRP,LFT,urea,creatinine)(-Baseline)
