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IRCT20230116057135N1 IRCT 2023-01-21 Tehran University of Medical Sciences The effect of NBS powder in treatment of patients with multi-drug resistant tuberculosis NBS-TB Evaluation of NBS herbal powder effects as a complementary medicine on the recovery of patients with multi-drug resistant tuberculosis 2023-02-20 anticipated 88 Complete https://irct.ir/trial/68062 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are divided into intervention and control groups by random block method. Allocation of the samples to two groups with random permutation block design will be two treatments with blocks of four. In this way, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the alternating combinations of the letters A, A, B, and B, which are 6 different combinations, on 6 cards in this order: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then a digit is randomly selected from 1 to 6. and continue this process until the sample volume reaches the quorum, Blinding description: In this study patients and researchers don't know which group of patients will use the Nutrition Bio-Shield (NBS). Physician and clinicians team know about the group who use the powder.‎. 3 Respiratory tuberculosis. Intervention 1: Intervention group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Nutrition Bio-Shield (NBS) powder will be prescribe is below: Dosage of NBS is 500 mg capsules daily in 4.5 grams given in divided doses of 1.5 gram in the morning, 1.5 gram in the noon and 1.5 gram in the night for 6 months. Intervention 2: Control group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Placebo capsules given in the morning, noon and night. 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 There is no further information.
public Mehrdad Mosadegh
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۸۶۴۵۱۳ +98 935 563 3390 m-mosadegh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Yousef Erfani
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۸۶۴۵۱۳ +98 912 424 5978 yerfani@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with multi-drug resistant tuberculosis Patients over 18 years old 18 years no limit Both The patient's withdrawal from the study Patients with any other chronic disease such as diabetes, cardiovascular disease, etc. Patients who have received supplements of vitamin D, zinc, B vitamins and other micronutrients in the last month. Patients who do not come for follow-up treatment at specified intervals Pregnant and lactating mothers Use of corticosteroids and immunosuppressive drugs Observing any drug sensitivity (especially digestive sensitivity to gluten) as determined by the attending physician Deterioration of the patient's clinical symptoms due to the consumption of Nutrition Bio-Shield (NBS) powder, as determined by the attending physician Patient's death during common and selective treatments (in case of death, the patient's information is fully recorded and laboratory tests are performed along with other samples to determine the possible effect of the drug on the patient's death) A15 Respiratory tuberculosis Treatment - Drugs Treatment - Drugs Intervention group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Nutrition Bio-Shield (NBS) powder will be prescribe is below: Dosage of NBS is 500 mg capsules daily in 4.5 grams given in divided doses of 1.5 gram in the morning, 1.5 gram in the noon and 1.5 gram in the night for 6 months. Control group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Placebo capsules given in the morning, noon and night. Microbial load. Timepoint: Before of the intervention, monthly monitoring, after of the intervention. Method of measurement: Examining the Ziehl–Neelsen staining slide, colony count. Measurement of white blood cells. Timepoint: Before of the intervention, After of the intervention. Method of measurement: Cell Counter. Measurement of inflammatory factors. Timepoint: Before of the intervention, After of the intervention. Method of measurement: Gold Standard Methods (Westergren method for ESR, Electrochemical Immunoassay for CRP). Tehran University of Medical Sciences Approved 2023-01-01 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Poursina St., Qods St., Enghelab St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)