Production of Effective Combinations of Terpenoids and Flavonoids of Teucrium Chamaedrys Extract and Evaluation of its Effect on Visual Function Indices in Patients with COVID-19.

Determining the impact of combination of effective terpenoid and flavonoid fractions derived from Teucrium chamaedrys extract on visual function indices in patients with COVID-19

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 132 patients. A table of random numbers was used for simple randomization.

The participants of this study are patients with COVID-19 referred to Tehran Army hospitals. Patients are divided into two groups of 66 intervention and control groups. In the intervention group, 0.04% eye drops will be used and in the control group, a similar placebo will be used for one week. The double-blinded study will be performed by assigning codes to each drug.

Inclusion criteria: the age between 25 and 40 years old; positive results of Real-time PCR tests, With symptoms of decreased vision when visiting the hospital. Exclusion criteria: history of underlying systemic diseases such as diabetes; history of eye diseases especially retinal lesions; best corrected visual acuity less than 20/30; history of cataract surgery; history of strabismus and amblyopia; use of drugs affecting the structure and function of the retina and visual system.

Intervention group: patients with COVID-19 that receiving 0.04% eye drops containing the effective combination of flavonoids and terpenoids for one week. Control group: patients with COVID-19 that receiving the same placebo eye drop in terms of shape, size, color and taste with 0.04% eye drops which containing the effective combination of flavonoids and terpenoids for one week.

Visual acuity; Color vision; Depth perception; Contrast sensitivity; Heterophoria; Near point of accommodation and convergence; Accommodative facility; Fusional vergence amplitudes and facility

Randomization method and description: Simple randomization. Randomization unit: individual. Randomization tool: Random number table and random allocation software. How to make a random sequence: A table of random numbers is a set of numbers that are produced without a specific pattern or order and in a completely random way and become a table. In order to use the table of random numbers, first the table will be predetermined for reading the numbers and then the relevant process will be done by considering the numbers for different groups in such a way that even numbers for intervention group 1 and odd numbers for intervention group 2 will be assigned. Concealment: In order to conceal random allocation, the method of sequentially numbered, sealed, opaque envelopes with random sequence will be used.

The method of blindness is done in such a way that the medicine and placebo will be prepared in the same form and will be given to the patients by a specialist. Each drug is assigned codes that the present design expert and researcher do not know the content of. In addition, the researcher collecting information does not know about the divided groups. Study data analyzers will also be unaware of the content of the groups. As a result, the patient, the researcher, the data analyst is unaware of the content of the groups. Patients are also asked to refrain from sharing work process information and how to receive medication with other patients. In case of possible side effects of drug use and change of treatment protocol, the patient code will be opened. The data entry software will be locked, so access to or change of data will not be possible. An independent person will be asked as the project supervisor to check all consent forms and make sure the consent forms are signed. Also, a number of patients will be randomly selected and asked about the treatment protocol.