Effect of herbal syrup and solution in treatment of COVID-19

Phase 2

Recruiting

Conditions: COVID-19.
COVID-19
U07.1

Registration Number: IRCT20200316046792N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Laboratory-confirmed COVID-19 cases (2019-nCoV Real-Time RT-PCR ), regardless of the clinical manifestations and history of close contact
Both the men and women, aged between 18 to 65 years old
Signing informed written consent
Highly suspected cases of COVID-19 based on positive findings of chest CT scan

Exclusion Criteria

5 days or more after the onset of illness
Pregnancy
Breastfeeding
History of drug allergy
Complicated cases with bacterial infection
Patients in recovery phase
Critical and severe cases such as ARDS
Clinical evidence for respiratory insufficiency at the time of hospitalization (SaO2 =90% or PaO2 < 8 kPa) in the patient breathing room air without oxygen therapy
Comorbidities (e.g. renal failure, liver failure, CHF, cerebrovascular and cardiovascular major diseases, chronic pulmonary disease, malignancy, endocrine and metabolic diseases, any immunodeficiency disorders such as AIDS, encephalopathy, neuropathy )

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to the treatment (Significant clinical improvement). Timepoint: At baseline and on the third, fifth, seventh, and tenth days after starting the treatment. Method of measurement: According to the clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (=37.2 ° C), respiratory rate (=24 breaths per minute), oxygen saturation (> 94% at room temperature) and cough (zero or mild) that persist for at least 24 hours. Cough will measure on a qualitative scale based on the patient's report . Other outcome variables will measure during clinical examination.;Complications of the treatment. Timepoint: Daily, until the tenth day. Method of measurement: Interview and patient's record.

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization. Timepoint: End of the treatment. Method of measurement: Patient's medical record.;Mortality. Timepoint: End of the treatment. Method of measurement: Patient's medical record (Clinical outcome).