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IRCT20230314057720N1 IRCT 2023-07-12 Shahre-kord University of Medical Sciences Effects of Thymex supplement syrup on autism symptoms in autistic children Therapeutic effects of Thymex supplement syrup on autism symptoms and blood levels of inflammatory markers in autistic children 2023-07-23 anticipated 50 Complete https://irct.ir/trial/69403 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Autism. Intervention 1: Intervention group: There are two types of Thymex syrup of Iran Darouk brand available in Iran, and for this study, we consider Thymex syrup of 140 ml Each 100 ml of Thymex Syrup contains 660 mg of Thymus vulgaris dry extract. The intervention group includes children with autism aged 3 to 10 years, children with autism 3 to 6 years old consume syrup 3 times a day and each time 2.5 ml, which is equivalent to a teaspoon, and children People with autism aged 6 to 10 years consume syrup 3 times a day and each time 5 ml, which is equivalent to two teaspoons. This group, at the same time as receiving Thymex syrup, receives the common treatment of autism, which depending on the patient can include drugs such as Risperidone, Aripiperazole or Methylphenidate. After 1 month of taking the drug according to the mentioned pattern, we will check the autistic behavior of the affected children by presenting a questionnaire based on the symptoms of autism to the parents of the affected. In order to investigate inflammatory markers and oxidative stress and to know the effect of the above drug on the levels of these markers, it is necessary to take a blood sample before the start of the study and a blood sample at the end of the 1-month study. The mentioned inflammatory factors are TNF-a and IL-1b, which are measured using an ELISA kit. The desired oxidative stress factors are malondialdehyde (MDA), antioxidant capacity (Total antioxidant capacity) and nitrite. Intervention 2: Control group: It includes children with autism between the ages of 3 and 10, who, like the intervention group, also receive common autism treatment, which, depending on the patient, can include drugs such as Risperidone, Aripiprazole, or Methylphenidate. At the same time, the members of the control group will receive the placebo, which is in the form of a syrup and made on the basis of ineffective medicinal substances, without the patient, researcher and project manager being informed. After 1 month of taking placebo according to the mentioned pattern, we will check the autistic behavior of the affected children by presenting a questionnaire based on the symptoms of autism to the parents of the affected. In order to investigate inflammatory markers and oxidative stress and to know the effect of the above drug on the levels of these markers, it is necessary to take a blood sample before the start of the study and a blood sample at the end of the 1-month study. The mentioned inflammatory factors are TNF-a and IL-1b, which are measured using an ELISA kit. The desired oxidative stress factors are malondialdehyde (MDA), antioxidant capacity (Total antioxidant capacity) and nitrite. Yes - There is a plan to make this available What will be shared: 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. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Rayehe Reisi
Unit 103, Block J, Fadak Complex, In front of Hamedanian Flower and Plant Market, Hamedanian Street, Hasht Behesht East Street, Isfahan
Isfahan Iran (Islamic Republic of) 8157966571 +98 31 3270 9027 reisirayehe@gmail.com Shahre-kord University of Medical Sciences scientific Rayehe Reisi
Unit 103, Block J, Fadak Complex, In front of Hamedanian Flower and Plant Market, Hamedanian Street, Hasht Behesht East Street, Isfahan
Isfahan Iran (Islamic Republic of) 8157966571 +98 31 3270 9027 reisirayehe@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Children with autism in the age range of 3 to 10 years 3 years 10 years Both The presence of drug interactions The presence of other diseases at the same time as autism Non-acceptance of the patient in taking medication regularly Non-cooperation of the patient in taking medication regularly F84.5 Asperger's syndrome Treatment - Drugs Treatment - Drugs Intervention group: There are two types of Thymex syrup of Iran Darouk brand available in Iran, and for this study, we consider Thymex syrup of 140 ml Each 100 ml of Thymex Syrup contains 660 mg of Thymus vulgaris dry extract. The intervention group includes children with autism aged 3 to 10 years, children with autism 3 to 6 years old consume syrup 3 times a day and each time 2.5 ml, which is equivalent to a teaspoon, and children People with autism aged 6 to 10 years consume syrup 3 times a day and each time 5 ml, which is equivalent to two teaspoons. This group, at the same time as receiving Thymex syrup, receives the common treatment of autism, which depending on the patient can include drugs such as Risperidone, Aripiperazole or Methylphenidate. After 1 month of taking the drug according to the mentioned pattern, we will check the autistic behavior of the affected children by presenting a questionnaire based on the symptoms of autism to the parents of the affected. In order to investigate inflammatory markers and oxidative stress and to know the effect of the above drug on the levels of these markers, it is necessary to take a blood sample before the start of the study and a blood sample at the end of the 1-month study. The mentioned inflammatory factors are TNF-a and IL-1b, which are measured using an ELISA kit. The desired oxidative stress factors are malondialdehyde (MDA), antioxidant capacity (Total antioxidant capacity) and nitrite. Control group: It includes children with autism between the ages of 3 and 10, who, like the intervention group, also receive common autism treatment, which, depending on the patient, can include drugs such as Risperidone, Aripiprazole, or Methylphenidate. At the same time, the members of the control group will receive the placebo, which is in the form of a syrup and made on the basis of ineffective medicinal substances, without the patient, researcher and project manager being informed. After 1 month of taking placebo according to the mentioned pattern, we will check the autistic behavior of the affected children by presenting a questionnaire based on the symptoms of autism to the parents of the affected. In order to investigate inflammatory markers and oxidative stress and to know the effect of the above drug on the levels of these markers, it is necessary to take a blood sample before the start of the study and a blood sample at the end of the 1-month study. The mentioned inflammatory factors are TNF-a and IL-1b, which are measured using an ELISA kit. The desired oxidative stress factors are malondialdehyde (MDA), antioxidant capacity (Total antioxidant capacity) and nitrite. Stereotyped behaviors of children with autism. Timepoint: Evaluation of stereotyped behaviors of children with autism before the start of the intervention and 30 days after the start of taking Thymex supplement syrup. Method of measurement: Gilliam's Autism Questionnaire. Communication in children with autism. Timepoint: Evaluation of communication in children with autism before the start of the intervention and 30 days after the start of Thymex supplement syrup. Method of measurement: Gilliam's Autism Questionnaire. Social interactions in children with autism. Timepoint: Evaluation of social interactions in children with autism before the start of the intervention and 30 days after the start of taking Thymex supplement syrup. Method of measurement: Gilliam's Autism Questionnaire. Developmental disorders in children with autism. Timepoint: Evaluation of developmental disorders in children with autism before the start of the intervention and 30 days after the start of taking Thymex supplement syrup. Method of measurement: Gilliam's Autism Questionnaire. Interleukin-1 beta inflammatory factor levels. Timepoint: Measurement the level of the inflammatory factor interleukin-1 beta in children with autism before the intervention and 30 days after the start of Thymex supplement syrup. Method of measurement: Measurement the level of the inflammatory factor interleukin-1 beta using an ELISA kit. TNF-alpha inflammatory factor level. Timepoint: Measurement the level of the inflammatory factor TNF-alpha in children with autism before the intervention and 30 days after the start of Thymex supplement syrup. Method of measurement: Measurement of TNF-alpha inflammatory factor level using ELISA kit. Malondialdehyde level. Timepoint: Measurement the level of malondialdehyde in children with autism before the intervention and 30 days after the start of Thymex supplement syrup. Method of measurement: Measurement the level of malondialdehyde using an ELISA kit. Total antioxidant capacity level. Timepoint: Measurement the level of total antioxidant capacity in children with autism before the start of the intervention and 30 days after the start of taking Thymex supplement syrup. Method of measurement: Measurement the level of total antioxidant capacity using an ELISA kit. Nitric oxide levels. Timepoint: Measurement of nitric oxide levels in children with autism before the intervention and 30 days after the start of Thymex supplement syrup. Method of measurement: Measurement of nitric oxide level using ELISA kit. Shahre-kord University of Medical Sciences Approved 2023-03-07 Ethics Committee of Shahrekord University of Medical Sciences Hajar Hospital, Parastar St, Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)