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tility of Medihope as an addon therapy for Covid 19 patients

Phase 3
Conditions
Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhereHealth Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
Registration Number
CTRI/2020/09/027975
Lead Sponsor
HopeAyurvedic Medicine Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Covid-19 patients diagnosed by RTPCR/ Rapid test, willing to participate and comply with all study procedures of the study.

2.Patients with or without history of Diabetes and/or Hypertension.

3.Patients willing to give written informed consent.

4.Patients of age more than 18 years of either gender.

5.Patients with mild (do not require oxygen, SpO2 100%) to moderate (require oxygen but do not require ventilatory support) symptoms of Covid-19 infection.

Exclusion Criteria

1.Patients with previous history of severe respiratory illness, viz Pneumonia, COPD.

2.Patients requiring Ventilatory support.

3.Pregnant and lactating women.

4.Patients with any other acute or chronic illness, viz Crohns disease, Congestive cardiac failure, rheumatoid arthritis, AIDS.

5.Patients receiving medication other than that for diabetes, hypertension.

6.Patients receiving any medication of traditional medicine.

7.Patients with history of allergy.

8.Patients with any psychiatric illness or history of drug abuse.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary:Chest radiograph, HRCT, SpO2 levels, Arterial Blood Gas and Status at discharge <br/ ><br>Secondary:temperature, respiratory symptoms and change in CBC, D-dimer, S. ferritin, IL-6, Vitamin D3, C-reactive protein, LDH, LFT, RFT & Duration of stay <br/ ><br>Timepoint: All the variables will be assessed at Day 1(baseline) and at Day 7 for the mild patients and day 15 for the moderate/severe patients <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Secondary:temperature, respiratory symptoms and change in CBC, D-dimer, S. ferritin, IL-6, Vitamin D3, C-reactive protein, LDH, LFT, RFT & Duration of stay <br/ ><br>Timepoint: Upto 15 days from the date of enrollment
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