Therapeutic effects of Thymex supplement syrup on autism symptoms and blood levels of inflammatory markers in autistic children

Determining the therapeutic effect of Thymex supplement syrup on autism symptoms and the level of blood inflammatory factors in autistic children

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 50 patients. The randomization method is random allocation. The randomization unit is an individual. The randomization tool is a sealed envelope.

For this study, we are considering Thymex 140 ml syrup. Each 100 ml of this syrup contains 660 mg of dry thyme plant extract. After obtaining the consent form from the parents of the patients, we have considered, for children aged 3 to 6 years, 3 times a day and 2.5 ml each time, and for children 6 to 10 years old, 3 times a day and 5 ml each time, for 1 month. The study is randomized, double-blind, that is, the participant, the clinical caregiver and the researcher do not know which patient will take the drug or placebo. Both groups receive standard autism treatment. Using the Gilliam questionnaire and measuring the level of inflammatory factors in the blood of the participants, the result of the intervention will be evaluated.

Children aged 3 to 10 with autism who do not have drug interactions due to the presence of a concurrent disease and the use of medication for its treatment, and who follow the study's consumption pattern and are willing to cooperate until the end of the study and are available.

The intervention group includes children aged 3-10. Children aged 3-6 take 2.5ml of syrup 3 times a day. children aged 6-10 take 5ml of syrup 3 times a day. Both groups receive standard autism treatment.

Level of blood inflammatory factors and behavior of autism patients

Patients will be gradually entered into the study in the treatment method and will be assigned to two intervention and control groups based on the random assignment method. For this purpose, we put the number of 50 cards with the letter A on 25 of them and the letter B on the other 25 in an envelope and randomly take out one card for each patient. The letter that comes out shows the group of the patient. Note that the doctor conducting the trial and the patient do not know about the syrups and B until the end of the study and the results, the study is double-blind.The randomization method is random allocation. The randomization unit is an individual. The randomization tool is a sealed envelope. The concealment is that cards A and B are placed in a sealed envelope and the allocator does not know the contents of the cards until the time of allocation.

The participant in the study and the physician conducting the clinical trial and the researcher as well as the outcome assessor in this study are blinded. Medicine and placebo will be provided in the same packaging from the pharmaceutical company. Attributing the drug and placebo to A and B is the responsibility of the drug distributor.

En To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

The access period will start 6 months after the results are published.

Our data will only be available to researchers working in academic and scientific institutions.

If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.

En In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address reisirayehe@gmail.com or the contact number 00989370084728.

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.