]>
IRCT20180513039641N2 IRCT 2020-07-27 Ghoum University of Medical Sciences Determination of dandelion capsule on patient with Covid-19 virus Determination of dandelion herbal capsule (Dandelherb) efficacy on symptom of patient with Covid-19 virus: a clinical trial study 2020-07-26 anticipated 80 Complete https://irct.ir/trial/49803 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be assigned to two groups of intervention and control by block randomization. For this purpose blocks of size 4 will be used. Six blocks will include BAAB, ABBA, BABA, BBAA, ABAB, AABB. A number from 1 to 6 is given to each of the mentioned blocks and then a random sequence of twenty is generated from 1 to 6 with Exell program and generate random numbers option. Afterward according to the relevant block, the treatment is assigned to the groups randomly. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end, Blinding description: This study will be performed in a double-blind manner. Unlabeled drugs in similar packages with a unique code will be prepared and a third person which don't contributed directly in the study, will be given the drugs to patients.In this case, patients will not inform the type of treatment they received. Also, the patient examining physician does not inform the type of received intervention. 3 Covid-19 infectious disease. Intervention 1: Intervention group: Oral yellow herbal Dandelion Capsule 300 mg with production license by the Managing Director of Nik Daroie Shafasaz Amiran Company and produced in Booali Daro Pharmaceutical Factory of Qom, 900 mg (3 capsules) per day after meals and for 40 days will be consumed by the candidates. It should be noted that hospitalized patients with positive COVID-19 test, also receive standard COVID-19 treatments, including interferon beta-1b, dexamethasone, and remdesivir. Intervention 2: Control group: Oral herbal Placebo Dandelion Capsule 300 mg contain starch and similar to dandelion cap (yellow) produced in Booali Daro Pharmaceutical Factory of Qom, 900 mg (3 capsules) per day after meals and for 40 days will be consumed by the candidates. It should be noted that hospitalized patients with positive COVID-19 test, also receive standard COVID-19 treatments, including interferon beta-1b, dexamethasone, and remdesivir. Yes - There is a plan to make this available What will be shared: After receiving the results of the study, there are plans to publish the article in valid journals When: all the time To whom: Depending on the journal in which the study is published Conditions: After receiving the results of the study, there are plans to publish the article in valid journals Where to obtain: Depending on the journal in which the study is published How to obtain: Depending on the journal in which the study is published Comments: Depending on the journal in which the study is published
public Reihaneh Tabaraie
Shaheed Beheshti Blvd
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 rt1356@yahoo.com Ghoum University of Medical Sciences scientific hoda Abolhasani
Pharmacology group, medicin faculty, Qom pardis university of medical sciences
Qom Iran (Islamic Republic of) 3716987366 +98 25 3320 9071 hodaabolhasani@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients Hospitalized in shaheed Beheshti Hospital in Qom with Covid-19 (their PCR test is positive). Patients between 18-65 years. Satisfaction of people to test this drug and its possible side effects. 18 years 65 years Both History of allergy to plants of asteraceae. bile duct and intestinal obstruction. acute cholecystitis, empyema, acute gall bladder inflammation. Gastrointestinal diseases, gastritis, irritable bowel syndrome. Diabetes and kidney failure. Alcohol consumption history (more than 10 grams per day for women and more than 20 grams per day for men). Pregnant and lactating women and Married women who are in childbearing age and do not use reliable contraception method. Weight below 50 kg Uncontrolled underlying diseases such as high blood pressure and .... Consumers of Lithium, digoxin, corticosteroids such as prednisone, niacin / nicotinic acid, metronidazole, disulfiram, tetracycline and fluoroquinolone antibiotics (such as ciprofloxacin), hypoglycemic drugs, antiplatelet drugs, diuretics, Antacids such as famotidine and s omeprazole. Consumers of s bloodroot, cat’s claw, chamomile, chaparral, chasteberry, damiana, Echinacea angustifolia, goldenseal, grapefruit juice, licorice, oregano, redclover,St.John’swort, wildcherry, andyucca. U07.1 Coronavirus infection :COVID-19, virus identified (a disease diagnosis of COVID-19 confirmed by laboratory testing) Treatment - Drugs Placebo Intervention group: Oral yellow herbal Dandelion Capsule 300 mg with production license by the Managing Director of Nik Daroie Shafasaz Amiran Company and produced in Booali Daro Pharmaceutical Factory of Qom, 900 mg (3 capsules) per day after meals and for 40 days will be consumed by the candidates. It should be noted that hospitalized patients with positive COVID-19 test, also receive standard COVID-19 treatments, including interferon beta-1b, dexamethasone, and remdesivir. Control group: Oral herbal Placebo Dandelion Capsule 300 mg contain starch and similar to dandelion cap (yellow) produced in Booali Daro Pharmaceutical Factory of Qom, 900 mg (3 capsules) per day after meals and for 40 days will be consumed by the candidates. It should be noted that hospitalized patients with positive COVID-19 test, also receive standard COVID-19 treatments, including interferon beta-1b, dexamethasone, and remdesivir. C-Reactive Protein. Timepoint: Measurement of C-Reactive Protein at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood test. White blood cell. Timepoint: Measurement of white blood cell at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood test. Red blood cell. Timepoint: Measurement of Red blood cell at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Hemoglobin. Timepoint: Measurement of hemoglobin at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood test. Albumin. Timepoint: Measurement of Albumin at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Alanine aminotransferase. Timepoint: Measurement of Alanine aminotransferase at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Aspartate transaminase. Timepoint: Measurement of Aspartate transaminase at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Creatinine. Timepoint: Measurement of Creatinine at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Blood Urea Nitrogen. Timepoint: Measurement of Blood Urea Nitrogen at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Total Bilirubin. Timepoint: Measurement of Total Bilirubin at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Direct Bilirubin. Timepoint: Measurement of Direct Bilirubin at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Alkaline Phosphatase. Timepoint: Measurement of Alkaline Phosphatase at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Blood Test. Blood oxygen saturation. Timepoint: Measurement of Blood oxygen saturation at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: Pulse Oximeter. CT scan of the lungs. Timepoint: Measurement of CT scan of the lungs at the beginning of the study (before the start of the study) and 40 days after the start of dandelion capsule. Method of measurement: CT scan. High sensitivity C-Reactive Protein. Timepoint: Before and after medication with Dandelion cap. Method of measurement: Blood Test. Ghoum University of Medical Sciences Approved 2020-07-21 Ethics Committee of Qom University of Medical Sciences No. 83, 4th alley, 1.1 alley, Safashahr Blvd Qom Ghoum Iran (Islamic Republic of)