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IRCT20210216050373N2 IRCT 2021-12-19 Imam Khomeini Hospital, Tehran Effectiveness of HMD 99 capsule (St. John’s wort and Lemon Balm extract along with DDW water) in the treatment of patients with COVID-19 disease Effectiveness of HMD 99 capsule (St. John’s wort and Lemon Balm extract along with DDW water) in the treatment of patients with COVID-19 disease referred to Imam Khomeini Hospital in Tehran: a randomized double blind clinical trial study. 2022-01-04 anticipated 110 Complete https://irct.ir/trial/60660 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A table of randomized numbers (with a number for each patient) shall be used for randomization of treatment in the study. In this table, half the numbers are coded for HMD 99 capsule and the other half for placebo without the administrators prior knowledge. Prescription of HMD 99 capsule or placebo for each patient shall be done by picking numbers from the table and matching them to the code for the medication or placebo, Blinding description: This is double-blind study in which neither the patients nor the medical care staff/physicians will have information regarding treatment (capsule or placebo) each patient is receiving. The double-blind set up of the study will use coded packages for capsules and placebo which look identical. 3 Covid-19. Intervention 1: Intervention group: This group shall receive 3 HMD 99 capsules per day, each containing 400 mg of Hypericum p. and Melissa o. formulation prepared with deuterium depleted water, for 90 days. Intervention 2: Control group: This group shall receive and take 3 placebo capsules (containing commonly used excipients in pharmaceuticals for producing placebo) for 90 days. 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 Work in progress
public Seyed Ahmad Alinaghi, M.D.
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Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1583 a_alinaghi@sina.tums.ac.ir Imam Khomeini Hospital, Tehran scientific Seyed Ahmad Alinaghi, M.D.
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Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1583 a_alinaghi@sina.tums.ac.ir Imam Khomeini Hospital, Tehran Iran (Islamic Republic of) To participate in the study, patients, or their legal guardian must give their knowing and voluntary consent in writing and orally The PCR test for SARS-CoV-2 virus must be positive with one of the following conditions: signs indicating covid-19 disease such as fever, dry cough and shortness of breath CT scan (HRCT or Spiral CT) to show coronavirus involvement, specifically in the ground glass view in the peripheral or basal portions of the lungs and physician's confirmation Patients who have signs of medical conditions secondary to covid-19 infection such as Acute Respiratory Distress Syndrome (ARDS) or myocarditis Patients should not have taken antiretroviral or boosters of immune system up to 3 months prior to the start of the study 18 years no limit Both Patients will not participate in this study during pregnancy or lactation Patients whose covid-19 infection has not been confirmed but have cold or flu-like symptoms. Current use of stimulants or depressant drugs or alcohol Use of growth hormone, testosterone or anabolic steroids up to 30 days prior to the start of the study Long-term treatment with immunosuppressant medications except topical steroids Patients undergoing chemotherapy, radiotherapy (up to 3 weeks prior to the start of the experiment) or patients who have been prescribed interferon U07.1 COVID 19, virus identified Treatment - Drugs Placebo Intervention group: This group shall receive 3 HMD 99 capsules per day, each containing 400 mg of Hypericum p. and Melissa o. formulation prepared with deuterium depleted water, for 90 days. Control group: This group shall receive and take 3 placebo capsules (containing commonly used excipients in pharmaceuticals for producing placebo) for 90 days Blood test (CBC, Diff-ESR-CRP-Ast-Alt-Cr-D Dimer). Timepoint: At the beginning, and after 14 days at the end of the study. Method of measurement: Blood Test CBC, (Diff-ESR-CRP-Ast-Alt-Cr-D Dimer). Clinical manifestations: Respiratory symptoms or common acute and non-respiratory symptoms such as lethargy, fever, myalgia, dry cough, phlegm, diarrhea, shortness of breath, rhinitis, vomiting, headaches, chills. Timepoint: daily for 14 days. Method of measurement: Physician's examination, patients answers, information recorded in patient files. Imam Khomeini Hospital, Tehran Approved 2021-12-15 Research Ethics Committee Of Islamic Azad University, Tehran Shariati St., Khaghani St. Tehran Tehran Iran (Islamic Republic of)