A Prospective, Randomized, Open label Three Armed Clinical study to assess the role ofVasa Ghana(whole Aqueous extract of Adhatoda vasica), Guduchi Ghana (whole Aqueousextract of Tinospora cordifolia) and Vasa-Guduchi Ghana (whole Aqueous extract ofAdhatoda vasica &Tinospora cordifolia combined) in management of symptoms andpreventing the progression of severity of the disease in SARS-CoV2 tested positiveasymptomatic and mild COVID-19 cases
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Length of time to clinical improvement/disease progression
研究概览
简要总结
The coronavirus 2019 (COVID-19) pandemic caused by a severe acute respiratory coronavirus (SARS-CoV-2) has become a global health issue. To date, it has infected more than 10 million people with 500 thousand fatalities worldwide. In India alone, the total number of positive cases
has reached 1.4 million (27 th July ’20). Ayurveda describes therapeutic usage of AV in form of aqueous extract (Kwath). The effect
of aqueous extract of AV on expression of molecular markers and genes associated with asthma and other hypoxia induced inflammation phenotypes has not been studied in detail. Similarly, the second herb, Tinospora cordifolia (Thunb.) Miers (TC), commonly named
Guduchi, is known for its immense applications in various diseases. The discovery of active components from the plant and their biological function in disease control gained a keen interest in the research field to explore and uncover the mechanism of its multi-dimensional
effect. As per Ayurveda, it is the best Rasayana. Besides, medicinal applications of T. cordifolia in countering various disorders and
conditions. It shows antioxidant, hepatoprotective, cardiovascular protective, anti- inflammatory, anti-pyretic, a thrombolytic agent, anti-microbial, and anti-cancer effects
A particular focus has been made on its health benefits in treating endocrine and metabolic disorders and its potential as an immune booster. Therefore, it would be interesting to see the direct effect of AV and TC individually and their combinatorial effect on SARS-CoV2 infection mediated molecular and clinical phenotype in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or mild symptoms Voluntariness to participate in the trial Patients who are able to take the drug orally and comply with study procedures.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
- •Age 19-65 years.
排除标准
- •COVID patients with symptoms classified as moderate, severe or critical.
- •Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria: Respiratory distress at room ambience (≥30 breaths per min) SaO2/ SpO2 < 90% on room air and requiring oxygen support for more than one hour to normalize.
- •PaO2/ FiO2 < 300 mmHg. Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for more than 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure.
- •(Adapted and modified from the reference: Yang Liu et al.
- •Lancet Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2) Individuals with uncontrolled, unstable co-morbidities/ co-existent medical illness such as diabetes, hypertension, cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern that may put the patient at increased risk during the study.
- •Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc.
- •and who are considered to be excluded from the study as evaluated by the investigators.
- •Individuals with pre-existing respiratory conditions Immuno-compromised individuals or those on immune suppressants.
- •History of immune suppression: solid organ or bone marrow transplant, use of immune suppressive anti-metabolic and biologic agents, intrinsic immune deficiencies, HIV infection.
- •Patients on or requiring parenteral nutrition Patients with known sensitivity or contraindication to any of the study medication.
- •COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials.
- •Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-
- •Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
- •Patient with known active hepatitis, and definite bacterial or fungal infections.
- •Patient with altered mental state.
- •Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration.
- •Patient with history of evidence of chronic interstitial infiltration at imaging.
- •Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immune deficiency virus.
结局指标
主要结局
Length of time to clinical improvement/disease progression
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Number of days of treatment and hospitalization
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Requirement of SOS medication- reason and no.of times
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Requirement of Rescue medication
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Percent mortality
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Changes in all the Lab parameters
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Duration of fever and respiratory symptoms
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Incidence of respiratory failure
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
Adverse events
时间窗: Length of time to clinical improvement/disease progression | Duration of fever and respiratory symptoms | Incidence of respiratory failure | Number of days of treatment and hospitalization | Requirement of SOS medication- reason and no.of times | Requirement of Rescue medication | Percent mortality | Adverse events | Percent mortality | Changes in all the Lab parameters
次要结局
- Length of time to clinical improvement/disease progression(Duration of fever and respiratory symptoms)