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
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2.Comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups.
研究概览
简要总结
Itis a prospective, randomized,open label, two arm, comparative clinical study to evaluate the efficacy andsafety of Fixed Ayurvedic Regimen (Zandu Chyawanprash + Zandu Pure Honey +Trishun Tablets + Immuzan Tablets) as an add on to Conventional treatment inthe management of Mild & Moderate COVID-19 patients for period of 8 weeks**.** The study will be carried out at 2-3 centres in India. Asper computer generated randomization list, subjects will be divided in group Aor group B. Subjects in group Awill be given Fixed Ayurvedic Regimen (Zandu Chyawanprash- 10-12 gm twice daily for 8 weeks + Zandu Pure Honey-1tsf twice daily for 8 weeks + Trishun Tablets - 1 tablet twice daily for 2weeks + Immuzan Tablets – 2 tablets twice daily for 8 weeks) as an add on to Conventionalmedication (SOC) as advised / prescribed by concerned health authorities for 8 weeks. Subjects in group B will beadvised to take Conventional medications (SOC) in the prescribed dosageas advised by the concerned health authorities for a period of 8 weeks. The primary objectives of the study will be toassess mean time (days) required for clinical recoveryfrom COVID-19 (Day of randomization to the day of clinical recovery and fromthe day of first noticed symptoms) and comparative assessment of post-clinicalrecovery (signs, symptoms, lab parameters) over a period of 8 weeks between thetwo groups. The secondary objectives will be to assess mean time (days) required for testing negative forSARS-CoV-2 on nasal or throat swab, change in duration of fever and otherrespiratory symptoms, changes on WHO Ordinal scale between the groups, changesin disease progression and requirement of Oxygen, ICU admission and VentilatorSupport, changes in percent mortality, post clinical recovery, lab parameters,rescue medication, healthstatus on WHO QOL BREF, between the groups, global assessment of overallchange as per the investigator and the subject and occurrence of AE, SAE on screeningvisit (day -3 to day 0), baseline visit (day 0), evaluation during hospitalization, day7, discharge visit, day 14, day 28, day 42 and day 56
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
2.Comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups.
时间窗: Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56
1.Mean time (days) required for clinical recovery from COVID-19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms)
时间窗: Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56
次要结局
- 1.Mean time (days) required for testing negative for SARS-CoV-2(2.Change in duration of fever and other respiratory symptoms and WHO Ordinal scale)