A prospective, interventional, single-arm clinical trial to evaluate the efficacy and safety of Ayurveda therapy protocol in the management of mild to moderate COVID-19 patients and its post complications
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of Ayurveda treatment protocol in management of Covid-19 and PostCovid complication.
研究概览
简要总结
TheCOVID 19 is now spreading throughout the world because of its high infectivityand communicability. Also, there is a lack in the proper management of thedisease. So, any contribution in the knowledge of treatment of COVID 19 fromany source could be of great value to the medical profession. Thus, the presentstudy is proposed to understand the safety and efficacy of Ayurveda therapyprotocol in managing the patients infected with SARS COV2/COVID 19 infection.The treatment protocol comprises a blend of poly herbo mineral formulations,which is formulated with the help of antiviral phytomolecules and processed andpurified natural metallic compounds as per Ayurveda principles. The drug usedin the treatment protocol comprises systematic herbal formulations withappropriate combinations, which are reported to have remarkable antiviral,antipyretic, immunomodulatory effects in treating patients. In the presentprospective, interventional, single-arm clinical trial to evaluate the efficacyand safety of Ayurveda therapy protocol as a standalone antiviral therapymanaging mild to moderate COVID-19 patients and its post complications. This Ayurvedatherapy protocol consist of a combination of three drugs and an eye drops i.e. PulmoCardcaps, Acalogen caps, Opthoxy eye drops and ZingiVir-H tablets. Adult subjectswho meet all inclusion criteria with COVID 19 positive assessment and mildCOVID 19 infection-related symptoms shall be screened into the study. In thepresent prospective, interventional, single-arm clinical trial to evaluate theefficacy and safety of Ayurveda therapy protocol in the management of mild tomoderate COVID-19 patients and its post complications. During this study, wewill know the efficacy and safety of Ayurveda therapy protocol in themanagement of COVID-19 and its Post complications. Further, we can assess thetime taken for RTPCR to become negative and normalize all clinical signs. Inaddition to this, we will also measure the following during the study period.1. To evaluate the effect of the treatment protocol in the blood coagulationprofile. 2. To evaluate the effect of the treatment protocol in complete bloodcount and basic inflammatory markers. 3. To evaluate the effect of thetreatment protocol on the Vitals of the subjects. (BP, HR, PR, RR, SpO2).Safety assessments will be done by assessing any adverse events or SAE in thestudy patients during the treatment period. Paper CRF shall be used in thestudy for data collection. Statistical analysis shall be done, and the studyresults shall be published. A clinical study report shall be prepared and willbe submitted to relevant regulatory authorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients tested positive for Covid-19 using RTPCR.
- •Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian.
排除标准
- •Subject or Authorized Representative is unable to provide informed consent.
- •Subject is pregnant or breastfeeding ladies.
- •Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
- •Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures.
- •A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding.
- •Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system or melena, hematemesis.
- •Inability to take oral medication
- •Prolonged QTc-interval in baseline ECG (>500 ms)
- •Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
- •Need of anticoagulants, antiplatelet agents, anti-thrombotics and thrombolytics during the treatment period.
- •Participation in another research study involving an investigational agent within 30 days prior to consent.
结局指标
主要结局
1. To evaluate the efficacy of Ayurveda treatment protocol in management of Covid-19 and PostCovid complication.
时间窗: During the therapy
2. To determine the safety of the Ayurveda treatment protocol.
时间窗: During the therapy
3. To assess the time taken for RTPCR to become negative and normalization of all clinical sign
时间窗: During the therapy
次要结局
- 1. To evaluate the effect of the treatment protocol in blood coagulation profile.(2. To evaluate the effect of the treatment protocol in complete blood count and basic)