Effect of Guduchyadi tablet (Tinospora based herbal formulation) in the management of newly diagnosed mild COVID-19 patients, to reduce the risk of hospitalization or death: A randomized double-blind placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 10
- 主要终点
- Percentage of participants with mild COVID-19 (as per ICMR guidelines, 2022) who are hospitalized and/or die due to COVID-19 through day 30
研究概览
简要总结
The intervention proposed under the project is a polyherbal combination based on traditional Ayurveda combined with scientific evidence for each ingredient’s clinical effect in relation to COVID-19. The combination consists of well-known Ayurveda herbs along with Tinospora cordifolia (Guduchi) and this herbal combination is expected to demonstrate immunomodulatory, antiviral, antipyretic, antitussive, pulmonary protective, and cardioprotective benefits. All ingredients of the combination are widely available in India as over-the-counter medicines or food products, and as food supplements in other countries like USA etc. The aim of this research study is to evaluate the effect of Guduchyadi tablets, a polyherbal formulation, on individuals with newly diagnosed mild COVID-19 infection through a phase 3 multi-centric clinical trial in India. This proposed therapeutic intervention to address COVID-19 related situations in the population with mild COVID-19 is expected to improve their quality of life, reduce clinical recovery time, and reduce the need for hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject aged 18 to 70 years (both inclusive) of both gender Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR) RT PCR negative COVID 19 suspected symptomatic subject defined as having strong suspicion of atleast 3 or more symptoms as per WHO or ICMR compatible with covid 19 and or having exposure to Covid 19 cases Subject with mild manifestations of COVID-19 (ICMR guidelines, 2022) 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 who is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
- •Subject with moderate, severe and critical COVID-19 (ICMR guidelines, 2022) Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days) Subject with underlying non-Communicable diseases like cardiovascular disease, hypertension, and CAD, DM (Diabetes Mellitus) and other immunocompromised states, active tuberculosis, chronic lung/kidney/liver disease, cerebrovascular diseases and obesity 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 on steroid or other immunosuppressive medication 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 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
Percentage of participants with mild COVID-19 (as per ICMR guidelines, 2022) who are hospitalized and/or die due to COVID-19 through day 30
时间窗: Day 1, Day 3, Day 5, Day 11-12,Day 15, Day 30/early termination visits
次要结局
- 1.Proportion of subjects with clinical worsening from baseline severity of COVID 19(2.Time from randomization to clinical worsening)