CTRI/2022/09/045632尚未招募2 期
To determine the clinical efficacy, safety and molecular mechanisms of Guduchyadi tablets in combating COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to negative COVID-19 RT-PCR test in subjects having RT-PCR confirmed mild COVID-19 (WHO 8-point Ordinal Scale Score 1 or 2)
研究概览
简要总结
The intervention proposed under the project is a polyherbal combinationbased on traditional Ayurveda combined with scientific evidence for eachingredient’s clinical effect in relation to COVID-19. The aim of the study isto evaluate the efficacy, safety and molecular mechanisms of Guduchyaditablets, a polyherbal formulation, in individuals with RT-PCR confirmed mildCOVID-19 through a Phase 2a: Pilot study in India. The combination consists ofwell-known Ayurveda herbs along with Tinosporacordifolia (Guduchi) and this herbal combination is expected to demonstrateimmunomodulatory, antiviral, antipyretic, antitussive, pulmonary protective,and cardioprotective benefits. Usedtogether, they are expected to speed recovery from COVID-19-related illnesswhile reducing complications, providing cardioprotection and improving qualityof life in COVID-19 patients with comorbid conditions. All ingredients of the combination are widelyavailable in India as nutraceuticals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject aged 20 to 60 years (both inclusive) of both gender Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR) Subject with mild manifestations of COVID-19 (WHO ordinal score 1 or 2) Subject with oxygen saturation ≥ 95% as measured by pulse oximetry Subject with initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization Subject with ability to swallow and retain oral medication Subject with willingness and ability to comply with trial and follow-up procedures Subject with ability to understand the nature of this trial and give written informed consent.
排除标准
- •Subject with RT-PCR positive COVID-19 with no symptoms Subject currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days) Subject having stage 2 hypertension (systolic blood pressure level > 160 mmHg and diastolic blood pressure of > 100 mmHg) Subject using more than 3 anti-hypertensive drugs Subject hospitalized for decompensated congestive heart failure in the last 12 months Subject having HbA1c > 9.0% Subject having Class 3 obesity (BMI ≥ 40) Subject with aspartate aminotransferase (AST)/alanine transaminase (ALT) more than 3 times the upper limit of normal reference range Subject who is pregnant, lactating or planning pregnancy during the study period Subject of childbearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion Subject with a history of receiving any allopathic or alternative (herbal) medication, any antiviral drugs with reported activity against COVID-19 (ivermectin, favipiravir, hydroxychloroquine, lopinavir, and remdesivir) or warfarin therapy for the present COVID-19 episode within 7 days before enrolment Subject on steroid or other immunosuppressive medication or having treatment within the last 3 months Subject with unstable or life-threatening systemic diseases like immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, carcinoma, respiratory failure and end stage renal disease Subject with a platelet count <100,000/μL or who have received a platelet transfusion in the 5 days prior to randomization.
- •Subject having hypersensitivity or other contraindication to any of the components of the study interventions as determined by the principal investigator.
- •Subject with conditions that could limit gastrointestinal absorption of tablet contents.
- •Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure Subject unlikely to comply with the procedure or complete the scheduled follow up visit, in the opinion of principal investigator Employee of the principal investigator or study center with direct involvement in the proposed study or other studies under the direction of that principal investigator or study center Other indication-based exclusion, in opinion of principal investigator.
结局指标
主要结局
Time to negative COVID-19 RT-PCR test in subjects having RT-PCR confirmed mild COVID-19 (WHO 8-point Ordinal Scale Score 1 or 2)
时间窗: Day-3to-1 Day8to9 Day11-12 Day15 Day30 or early termination visit
次要结局
- subjects with negative RT-PCR confirmed COVID-19 through day 30(Time to decline in viral load)
研究者
研究点 (1)
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