A study to assess the effectiveness of Ayurvedic formulation in addition to standard of care in COVID-19 positive patients in a tertiary hospital.

Phase 3

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/04/024882
• Lead Sponsor: Ministry of AYUSH Government of India

Brief Summary

The project is aimed to assess the effect in clinical outcomes fromadministering an integrative medicine protocol which subsumes Ayurvedicinterventions as part of the standard of care COVID 19 management versusclinical outcomes in COVID 19 patients being administered standard of carealone with following objectives

 Primary objectives:    Assessingthe effect of the Ayurveda drug combination of Tinospora cordifolia and Piperlongum in the progression of the disease, its severityand clinical outcome.

 Secondary objectives:    Studythe progress of the disease in detail and in real-time to develop betterunderstanding of the pathogenesis and different stages of the disease fromAyurvedic perspective, clinical data and observations based on patient responseto interventions.

 2.     Correlatingthe clinical investigation parameters of different stages of the pathogenesiswith Ayurveda understanding of the sub-stages of the disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age > 18 years Written Informed consent is documented COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test.
• Can take oral medicines Mild-moderate grade of the disease Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.

Exclusion Criteria

Known sensitivity to any of the ingredients Bleeding haemorrhoids Serious stages of the illnesses ICU admitted patients Pre-existing GI symptoms like nausea or vomiting.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Percentage of patients progressing to serious/critical stage of disease	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
No. of days taken to test negative for COVID, total days to discharge frm hospital	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Progress of disease as per clinical severity score (COCSS)	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Profiling acc to tridosha	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Defining the disease according to Ayurveda	Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc

Secondary Outcome Measures

Name	Time	Method
No. of days to first clinical symptoms, and what it is	No. of days to and of GI symptoms and what they are

Trial Locations

Locations (1)

Medanta Institute of Education and Research; 🇮🇳 Gurgaon, HARYANA, India

Medanta Institute of Education and Research

🇮🇳Gurgaon, HARYANA, India

DrSushila Kataria

Principal investigator

9971918887

drsushilakataria@gmail.com