Safety and efficacy of Ayurvedic Capsule in mild to moderate COVID-19 infection.

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/07/026570

Lead Sponsor: AMAI Charitable Trust Pune

Brief Summary: COVID -19 is a respiratory illness that has led to a pandemic, affecting more that 200 countries in the world. Due to sudden advent and rapid spread of infection, no antiviral drug has been found to be effective since its onset. (Tab. Favipiravir is approved though, itâ€™s efficacy in population at large, in real-world setting is yet to be confirmed)

While there is no medicine for COVID-19 as of now, enhancing the bodyâ€™s immunity should play an important role in maintaining optimum health and the IP (study drug) might possibly play an important role in enhancing immunity. The capsule contains ghana of Withania somnifera, Terminalia chebula, Tinospora cordifolia, Asparagus racemosus, Emblica officinalis etc.

Role of study drug as an antiviral will also be tested by frequent naso-pharyngeal and oro-pharyngeal swabs.

This is prospective, double blind study aims to assess the efficacy and safety of Cap. IP in the management of COVID 19 patients and also in boosting innate immunity. Secondary objectives are, to assess efficacy of Cap. IP in restoring respiratory health, in early recovery of patients and to assess safety of Cap. IP.

Trial Overview

Total 72 patients were enrolled in the study.1st patient was enrolled on 11 Aug 2020 and Last patient was enrolled on 3 Sep 2020.Follow up visits completed on 5 Oct 2020.

Protocol published under BMC.

1

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Age > 18 years 2.All sexes 3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.
Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%).
OR 4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR 5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air, where no alternative explanation for respiratory symptoms can be given.

Exclusion Criteria

1.Pregnant or lactating women 2.Symptoms of acute respiratory tract infection for more than seven days 3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment 4.Subject is also a participant of any other clinical trial 5.Serious / long-standing co-morbid conditions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.	1 month

Secondary Outcome Measures

Name	Time	Method
Assessing safety of Cap. IP	1 Month
Efficacy of Cap. IP in early recovery of patients	1 Month
Efficacy of Cap. IP in restoring respiratory health	1 Month

Trial Locations

Locations (1): Yashwantrao Chavan Memorial Hospital
🇮🇳
Pune, MAHARASHTRA, India
Yashwantrao Chavan Memorial Hospital
🇮🇳Pune, MAHARASHTRA, India
Susmita Wani
Principal investigator
8793930577
susmitawani@gmail.com