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IRCT20211218053445N1 IRCT 2022-07-19 Babol University of Medical Sciences The effect of herbal products of Iranian traditional medicine (Ziziphus jujuba, Glycyrrhiza glabra, and Cydonia oblonga) on the symptoms of patients with COVID-19 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 2022-07-22 anticipated 146 Complete https://irct.ir/trial/60741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2 COVID-19 disease. Intervention 1: 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. Intervention 2: Control group: A placebo product with the same color and consistency is prepared for these patients. In order to homogenize the smell, the extract is added in the amount of 1%. Carboxymethyl cellulose (CMC) (0.5-1%) is used in order to achieve the appropriate viscosity for the placebo formulation. Sodium benzoate and potassium sorbate (0.3 and 0.2%, respectively) are added to the mixture as microbial preservatives and administered orally in the same way as the intervention group, i.e. in two divided doses every 12 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mohammad Hosein Manian
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 4728 Alimanian94@gmail.com Babol University of Medical Sciences scientific Morteza Mojahedi
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 4730 Mortazamojahedy@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Being between 18 and 75 years old Definite diagnosis of Covid-19 disease based on PCR test or lung CT scan 18 years 75 years Both Pregnancy and breastfeeding History of any allergy to product components Patient's hypercapnia Loss of consciousness B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo 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 product with the same color and consistency is prepared for these patients. In order to homogenize the smell, the extract is added in the amount of 1%. Carboxymethyl cellulose (CMC) (0.5-1%) is used in order to achieve the appropriate viscosity for the placebo formulation. Sodium benzoate and potassium sorbate (0.3 and 0.2%, respectively) are added to the mixture as microbial preservatives and administered orally in the same way as the intervention group, i.e. in two divided doses every 12 hours. Fever duration. Timepoint: After the intervention. Method of measurement: Thermometer(length of days the patient has a fever). Fever severity. Timepoint: After the intervention. Method of measurement: Thermometer. Arterial oxygen saturation. Timepoint: After the intervention. Method of measurement: pulse oximeter. Cough severity. Timepoint: After the intervention. Method of measurement: Cough Severity Index (CSI). Babol University of Medical Sciences Approved 2022-05-29 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)