Assessment of efficacy of the Indigenous poly herbal drug Desandun Kalka” against mild symptomatic patients with SARS-CoV- 2 infection - A randomized clinical trial

Phase 2

Conditions: SARS-CoV- 2 infection

Registration Number: SLCTR/2021/005

Lead Sponsor: Department of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

* Age > 18 years
• Both male and female
* PCR positive for SARS-CoV- 2
* The patient clinically assessed and categorized according to the tool published by Min. of Health, Sri Lanka, Provisional Guidelines for Clinical Management of COVID-19, (March 2020)” as patients with mild symptoms of SARS COVID-19 infection and defined as below:
- Respiratory Rate (RR/min) 12 – 20
- Heart Rate (HR/min) < 100
- O2 Saturation – on room air (% by Pulse Oxymeter) > 94

Exclusion Criteria

* Pregnant and breast feeding mothers
* Those with severe and moderate illness (COVID 19)
* Chronic Liver Cell Disease (CLCD),
* Chronic Kidney Disease (CKD)
* Those who are unable to take the drug orally

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A more than 50% reduction in the duration of illness (cough, fever, sore throat & anosmia) - defined below [at baseline, day 7, and day 10 from the time of treatment begins]<br>Number of days taken for the patient to be afebrile for 72 hours [at baseline, day 7, and day 10 from the time treatment begins]<br>Number of days taken for a more than 50% reduction in cough by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins]<br>Number of days taken for a more than 50% reduction of sore throat by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins]<br>Number of days taken for a more than 50% reduction in resolution of anosmia by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins]<br>

Secondary Outcome Measures