Evaluating efficacy of Kelofan syrup, a traditional Iranian medicine product on pulmonary & other clinical and laboratory manifestations of patients with or probable of covid-19

Evaluating efficacy of Kelofan syrup on pulmonary & other clinical and laboratory manifestations of patients with probable or confirmed COVID-19

This study is a randomized controlled clinical trial on hospitalized patients with probable or confirmed COVID-19. Individuals with eligibility criteria will be randomly divided into two groups of intervention and control, and 30 patients will be enrolled in each group. The study is three-blinded and the patient, the nurse giving the medication, the data collector, and the data analyzer are not aware of the type of assignment.

This study will be carried out at Imam Khomeini Hospital, one of the hospitals affiliated to Ardabil University of Medical Sciences. This hospital has been assigned for COVID-19 patients. This research will be carried out from May to July of 2020.

Inclusion criteria: Patients over 18 years old hospitalized with or probable of COVID-19 based on Radiological findings or Positive PCR test according to the instructions of the Ministry of Health; Clinically classified as moderate and severe, no need for intubation; written and informed satisfaction of patients Non-inclusion: Liver, kidney and heart failure; History of allergies to medicinal herbs; Immunodeficiency; Uncontrplled Hypertension; Uncontrolled Diabetes; Alcohol or drug addiction

Patients are receiving a herbal formulation (Kelofan syrup) in form of a syrup at a dose of 7.5 cc two times a day for a maximum of seven days, in addition to standard treatment.

Respiratory rate per minute; O2 Saturation

Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment).The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Iranian medicine products and control group (Assignment). Then based on blocks and allocation sequences medication will be given to patients

In this study, patients will be informed by consent form that they would either be in the intervention group or the control group, but they won't be aware of the type of medication. Nurses who supply the drug are also unaware of its content because the appearance, taste, color, and prescription of the drug are similar, but the code on the drug will be different. The written codes on the drugs are random and only the non-involved researcher is aware of the drug type and the inserted code on it. The patient data collector and the project statistical partner are also unaware of the type of intervention. As the control group uses placebo, which is similar in appearance, taste, color, and prescription, patients will be unaware of the type of drug being administered.