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IRCT20100601004076N26 IRCT 2021-10-23 Ghadiminezhad Daru Determining the Safety and Effectiveness of ENDOR Oral Combination Drug in the Treatment of Patients with Covid-19 Determining the Safety and Effectiveness of ENDOR Oral Combination Drug in the Treatment of Patients with Covid-19 Referred to Imam Khomeini Hospital in Tehran 2021-11-22 anticipated 200 Complete https://irct.ir/trial/54315 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is used. Random number table is a set of numbers that are generated completely randomly and are tabulated. Firstly, we determine the direction of the random number table and then we decide to read the random number table from above. Then we consider even numbers for the intervention group and odd numbers for the control group. We assign 200 codes from 1 to 200 to the patients hospitalized to the ward. Then we put patients with even code in the intervention group and patients with odd code in the control group. Thus, a total of 200 people will be assigned to the intervention and control groups, Blinding description: For reducing the bias, single-blind method was taken into account. Placebo capsules were used to prevent patients from being informed about which group they are belonging to, Control or Intervention. Placebo capsules are designed to be similar in color and size to Endor capsules. In this study, patients will not be aware of which group they are in, the rest of the study members are aware of patients grouping. 3 COVID-19. Intervention 1: Intervention group: In this study, the intervention group, in addition to the standard treatment according to national protocol, consumes two oral capsules of Endor every eight hours for seven days. This capsule contains Betacarotene -2.5mg, Curcuma longa rhizome extract equiv. to dry- 1.25g, (Equiv. Curcumin- 23.75mg), Fish Oil – Rich in Omega 3 acids- 250mg, (Equiv. Docosahexaenoic acid [DHA]-30mg), ](Equiv. Eicosapentaenoic acid [EPA]- 45mg), (Equiv. Omega 3 marine triglycerides-75mg), Sodium ascorbate-56.8mg, (Equiv. Ascorbic acid [Vitamin C]-50mg ), Wheatgerm Oil – 75mg, Zinc Sulfate – 27.62mg, (Equiv. Zinc – 10mg). This capsule has been manufactured by Ghadiminezhad Daru. Intervention 2: Control group: Treatment based on National Protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to classified information of the patients
public SeyedAhmad SeyedAlinaghi
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Basement of the Infection department (Building 6) - Iranian Research Center for HIV/AIDS
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1583 s_a_alinaghi@yahoo.com Tehran University of Medical Sciences scientific Minoo Mohraz
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Basement of the Infection department (Building 6) - Iranian Research Center for HIV/AIDS
Tehran Iran (Islamic Republic of) ۷۳۳۱۴۱-۱۹-۱۴ +98 21 6658 1583 minoomohraz@ams.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Informed and voluntary oral and written consent of the patient or his / her guardian to participate in the study Age over 18 years SARS-CoV-2 virus PCR test positive or having one of the following conditions: Strong symptoms of COVID-19 disease, including fever, dry cough, and shortness of breath Existence of CT scan confirming lung involvement, especially ground glass view 18 years no limit Both Individuals whose Covid-19 test has not been approved Individuals who use drugs Individuals who drink alcohol Individuals who use immunosuppressive drugs Individuals under chemotherapy or radiotherapy Individuals who use growth hormone, testosterone and anabolic steroids B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In this study, the intervention group, in addition to the standard treatment according to national protocol, consumes two oral capsules of Endor every eight hours for seven days. This capsule contains Betacarotene -2.5mg, Curcuma longa rhizome extract equiv. to dry- 1.25g, (Equiv. Curcumin- 23.75mg), Fish Oil – Rich in Omega 3 acids- 250mg, (Equiv. Docosahexaenoic acid [DHA]-30mg), ](Equiv. Eicosapentaenoic acid [EPA]- 45mg), (Equiv. Omega 3 marine triglycerides-75mg), Sodium ascorbate-56.8mg, (Equiv. Ascorbic acid [Vitamin C]-50mg ), Wheatgerm Oil – 75mg, Zinc Sulfate – 27.62mg, (Equiv. Zinc – 10mg). This capsule has been manufactured by Ghadiminezhad Daru Control group: Treatment based on National Protocol Complete Blood Count (CBC), Differentiation. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Tests. Erythrocyte sedimentation rate (ESR). Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Test. C-Reactive Protein (CRP). Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Test. Alanine Aminotransferease (ALT). Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Test. Aspartate aminotransferase (AST). Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Test. Creatinine. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Tests. Di-Dimer Test. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Laboratory Tests. Respiratory Presentations. Timepoint: During Hospitalization. Method of measurement: Clinical Examination. Weakness and lethargy. Timepoint: During Hospitalizations. Method of measurement: Clinical Examinations. Fever. Timepoint: During Hospitalization. Method of measurement: Clinical Presentations. Myalgia. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Dry Cough. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Existence of sputum. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Sore throat. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Diarrhea. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Shortness of breath. Timepoint: During Hospitalization. Method of measurement: Clinical Examination. Rhinitis. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Nausea. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Headache. Timepoint: During Hospitalization. Method of measurement: Clinical Examinations. Shivering. Timepoint: During Hospitalization. Method of measurement: Clinical Examination. Presence of ground-glass appearance. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Chest X-ray. Alveolar Complication. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Chest X-ray. Unilateral or bilateral pulmonary involvement. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Chest X-ray. Location of Involvement. Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Chest X-ray. Presence of Acute respiratory distress syndrome (ARDS). Timepoint: During Three days of Hospitalization and at the time of discharging. Method of measurement: Chest X-ray. Ghadiminezhad Daru Approved 2021-09-19 Ethics Committee of Tehran University of Medical Sciences Iranin Research Center for HIV/AIDS, Qarib street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)