CTRI/2021/01/030733已完成2 期
A Prospective, Randomized, Open Label, two arm, comparative clinical study to evaluate the efficacy and safety of Fixed Ayurvedic Regimen (Zandu Chyawanprash plus Zandu Pure Honey plus Trishun Tablets plus Immuzan Tablets) as an add on to Conventional treatment in the management of Mild & Moderate COVID 19 patients for period of 8 weeks - NI
Emami Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19
- •2.Clinical presentation with Laboratory (RT-PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID-19
- •3.Subjects having symptoms not more than 3 days
- •4.Ready to provide written informed consent for participation in the study
- •5.Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt/ local health authority throughout the study period.
排除标准
- •1.Patients with known history of Diabetes Mellitus
- •2.Patients having difficulty in swallowing oral medications.
- •3.AYUSH system-based contraindications
- •4.Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria
- •(i) Respiratory distress at room ambience (Greater than or equal to 30 breaths per min)
- •(ii) Oxygen saturation at rest less than or equal to 93 percent (peripheral digital oxymeter) and requiring oxygen support for over one hour to normalize
- •(iii) 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 over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure.
- •5.Patients who have participated in other clinical trials within last 1 month;
- •6.Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
- •7.Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
- •8.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
- •9.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
- •10.Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study
- •11.Allergies, known to be allergic to Investigational Products (Ayurvedic Formulations)
- •12.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
研究者
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