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IRCT20210325050769N1 IRCT 2021-04-12 Bagheiat-allah University of Medical Sciences Evaluation of the effect of herbal therapeutic supplements (Marsh - Mallow, Sweet violet, Malva sylvestris, Damask rose, Liquorice root) against corona disease Evaluation of the effect of CRSM-X7 herbal therapeutic supplement in the improving of symptoms of patients with COVID-19 hospitalized in the medical centers. 2021-04-19 anticipated 200 Complete https://irct.ir/trial/55493 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: block, Randomization unit: individual Randomization layers: age, sex, disease severity Randomization tool: A sealed envelope containing the number of blocks How to build a sequential image: based on blocks with size of 4 and 6 . 2-3 COVID-19. Intervention 1: Intervention group: The drug (including tea, honey and royal jelly for 5 days) is delivered to the hospital along with the list of codes of patients in the intervention group (to be presented to patients in the intervention group).The composition inside each CRSM-X7 tea bag includes 10 grams of marshmallow, 5 grams of Sweet violet, 5 grams of Wild mallow, 5 grams of Damask rose, 10 grams of Liquorice root. After identification and registration, they will be placed in special bags for use. Each bag of CRSM-X7 herbal tea is infused in a volume of 300 ml of boiling water for one day use. After the temperature of the drink is reduced (it reached the temperature of 40 ° C), 5 cc of lavender honey is added, dissolved in it and drunk. So that, three glasses (each glass is equivalent to 100 ml) will be drunk per day (half an hour before breakfast, one hour before lunch, one hour before bedtime) up to five days by the intervention group. The seventh element of this supplement is Royal Jelly, which is prepared in the proportion of 50 grams of Royal Jelly in one kilo gram of lavender honey and should be used by the people under study 4 meals a day, ie morning, noon, evening, night for 5 days (each Promise of 2.5 cc). Intervention 2: Control group: Control group: 92 people are in the control group, which includes other patients and hospitalized in the same treatment center who receive a standard treatment regimen similar to the intervention group. Yes - There is a plan to make this available What will be shared: All study documents which includes the variables studied in the studywill be shared and made available after the publication of the article, without any conditions. When: The access period will start after the article is published in a scientific journal To whom: All people, including researchers working in academic and scientific institutions, or people working in industry, will be able to access the data. Conditions: Once the article has been published in an international journal, there are no preconditions for accessing the data to perform any type of analysis on the delivered data. Where to obtain: Baqiyatallah University of Medical Sciences, Traditional Medicine Research Center / Gastroenterology and Liver Research Center How to obtain: After the data is published in an international journal, information will be provided with a simple, basic written request without any formalities. Mohamad.heiat@gmail.com Comments:
public Ahmad-Reza Sharifi Alvan Abadi
Mollasadra- south Sheikh Bahaei
Tehran Iran (Islamic Republic of) 1939-55487 +98 21 8861 4523 sharifiahmaddr@gmail.com Bagheiat-allah University of Medical Sciences scientific Ahmad-Reza Sharifi Alvan Abadi
Mollasadra- south Sheikh Bahaei
Tehran Iran (Islamic Republic of) 1939-55487 +98 21 8861 4523 sharifiahmaddr@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of COVID-19 Age 18-65 Having informed and written consent to participate in the study 18 years 65 years Both Disagreement of the physician directly responsible for the patient Pregnancy and breastfeeding Allergies to the drug elements Symptoms of gastrointestinal, liver or kidney disease Incidence of drug interactions Patient dissatisfaction to continue the project for any reason Inability of the patient to receive oral medication Hypertension Having heart failure Do not take anticoagulants (aspirin, Plavix, warfarin) U07.1 COVID-19, virus identified Treatment - Other Treatment - Other Intervention group: The drug (including tea, honey and royal jelly for 5 days) is delivered to the hospital along with the list of codes of patients in the intervention group (to be presented to patients in the intervention group).The composition inside each CRSM-X7 tea bag includes 10 grams of marshmallow, 5 grams of Sweet violet, 5 grams of Wild mallow, 5 grams of Damask rose, 10 grams of Liquorice root. After identification and registration, they will be placed in special bags for use. Each bag of CRSM-X7 herbal tea is infused in a volume of 300 ml of boiling water for one day use. After the temperature of the drink is reduced (it reached the temperature of 40 ° C), 5 cc of lavender honey is added, dissolved in it and drunk. So that, three glasses (each glass is equivalent to 100 ml) will be drunk per day (half an hour before breakfast, one hour before lunch, one hour before bedtime) up to five days by the intervention group. The seventh element of this supplement is Royal Jelly, which is prepared in the proportion of 50 grams of Royal Jelly in one kilo gram of lavender honey and should be used by the people under study 4 meals a day, ie morning, noon, evening, night for 5 days (each Promise of 2.5 cc). Control group: Control group: 92 people are in the control group, which includes other patients and hospitalized in the same treatment center who receive a standard treatment regimen similar to the intervention group. Hospitalization time. Timepoint: Before starting the study and after 5 days of using herbal supplements. Method of measurement: A researcher-made questionnaire whose validity and reliability have been assessed. Iranian Matin Gene Co. Approved 2020-10-12 Research Ethics Committee of Baqiyatallah University of Medical Sciences Mollasadra-south Shikh bahaei Tehran Tehran Iran (Islamic Republic of)