Investigating the effect of herbal products of Iranian traditional medicine (Ziziphus jujuba, Glycyrrhiza glabra, and Cydonia oblonga) on the symptoms of patients with COVID-19

Determining the effect of herbal products of Iranian traditional medicine (Ziziphus jujuba, Glycyrrhiza glabra, and Cydonia oblonga) on the symptoms of patients with COVID-19

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 will be conducted on 146 patients. Sampling will be block randomization.

Eligible patients with covid-19 are selected from Masih Deneshvari in Tehran, Razi in ghaemshahr, shahid beheshti in Kashan and Nekoui, Hedayati, Forghani in Qom Hospitals. Hospitals and randomly divided into two groups. The pharmacist's colleague fills the contents of the bottle with the desired drugs (syrup and placebo) therefore, all collaborators will be blind. Placebo syrup will be used for the control group. However, for the intervention group, syrup made from Ziziphus jujube, Glycyrrhiza glabra, and Cydonia oblonga was administered orally in a daily dose of 32 grams in two divided doses, and then the results were compared in the two groups.

Inclusion criteria: Having an age between 18 and 75 years and a definite diagnosis of the disease of Covid-19 based on the PCR test or lung CT scan. exclusion criteria: Pregnancy and breastfeeding, History of any allergy to product components, Patient's hypercapnia, Loss of consciousness

Intervention group: For these patients, the syrup made from Ziziphus jujube, Glycyrrhiza glabra, and Cydonia oblonga is prescribed orally in a daily dose of 32 grams (equivalent to 27 ml) in two divided doses every 12 hours. Control group: A placebo with the same color and consistency is prepared for these patients and administered orally in the same way as the intervention group, i.e. in two divided doses daily.

Arterial oxygen saturation, dyspnea severity, duration of dyspnea, fever severity, duration of fever

The sampling method will initially be available; Then the samples will be placed in blocks of ten by random block sampling method. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 2 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Use non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.

The pharmacist's colleague, who does not have access to the subjects, fills the contents of the bottle with the desired drugs (syrup and placebo) according to the sequence he has. He knows which drug group each number belongs to. Subjects receive the envelope and go to the medicine delivery official and according to their envelope number, they will receive a box that matches the same number. Therefore, except for the pharmacist, all project collaborators will be blind to the content of what the subjects receive.