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IRCT20210216050373N3 IRCT 2022-03-14 Vice Chancellor of Research, Tehran University of Medical Sciences The evaluation of effect of herbal supplement (Melissa Officinalis and Hypericum perforatum along with DDW water) on the improvement of clinical symptoms, CD4 level and the viral load of HIV positive patients The evaluation of effect of herbal supplement (Melissa Officinalis and Hypericum perforatum along with DDW water) on the improvement of clinical symptoms, CD4 level and the viral load of HIV positive patients: A randomized double blind clinical trial study 2022-02-20 anticipated 100 Complete https://irct.ir/trial/61713 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 AIDS. 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 Seyed 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 Seyed 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) Patients must give their knowing and voluntary written consent to join the study Patients must have at least two positive ELISA HIV test results Patients who have failed to benefit from anti-retroviral drugs due to drug resistance 18 years 65 years Both Patients with undetectable levels of blood viral content Patients with Hepatitis B or C Pregnancy and lactation Patients who have used immuno-enhancers; use of antibiotics and other prescribed medication to treat AIDS symptomology is excepted Present use of illegal drugs or alcohol Use of growth hormone 30 days prior to the study Use of testosterone or anabolic steroids 30 days prior to the study Chemotherapy, radiotherapy or interferon treatment 3 weeks prior to entering the study 042 Human immunodeficiency virus (HIV) disease 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 HIVAb. Timepoint: AT the beginning and the ending of the study. Method of measurement: HIVAb ELISA. CBC. Timepoint: At the beginning and the ending of the study. Method of measurement: Blood Test. Viral Load. Timepoint: Beginning and the ending of the study. Method of measurement: PCR. AIDS-related clinical signs and drug interactions. Timepoint: Weekly during the course of the study. Method of measurement: Physician's examinations and phone calls in case of occurrence of sings and symptoms. Vice Chancellor of Research, Tehran University of Medical Sciences Approved 2022-02-01 Ethics Committee in Research Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Keshavarz Blvd., Dr. Gharib Street Tehran Tehran Iran (Islamic Republic of)