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IRCT20210531051459N2 IRCT 2022-04-08 Mashhad University of Medical Sciences The assessment of quercetin in patients with human T-cell lymphotropic virus type 1-associated myelopathy The effect of quercetin on inflammatory cytokines and clinical signs of patient with human T-cell lymphotropic virus type 1-associated myelopathy/tropical spastic paraparesis (HAM/TSP): The randomized clinical trial 2022-06-05 anticipated 40 Complete https://irct.ir/trial/62510 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type: Block Randomization unit: Individual Randomization tool: www.sealedenvelope.com How to create a random sequence: At www.sealedenvelope.com, the randomization section, after selecting the list, specifies the number of groups, the size of the blocks (4, 8, 10, 16) and the length of the list, and provides the list accordingly. Allocation Concealment: Sealed envelopes Participants are given an envelope according to which they are placed in one of two groups, Blinding description: In this study, participants did not know the type of treatment they received. Also, patient clinicians, physicians, and outcome assessors are unaware of how patients are grouped and use medication or placebo. 3 Human T-cell lymphotropic virus associated myelopathy. Intervention 1: Intervention group: The enrolled patients take one 500 mg quercetin capsule daily for 12 weeks, in addition to routine treatment (gabapentin). Intervention 2: Control group:The enrolled patients take one placebo capsule daily for 12 weeks in addition to routine treatment (gabapentin). The placebo capsule contains starch and is similar in appearance, weight and packaging to quercetin capsules. Yes - There is a plan to make this available What will be shared: Potential data can be shared after participants are not identified. When: Access period will be started 9 months after the published results. To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: The use of data and its analysis is allowed by mentioning the source. Where to obtain: It is necessary to send an email to the corresponding author of the article for receiving the data. How to obtain: The processes that a researcher who requests data goes through will include a letter of request from the person, a letter of request from the center or university of origin, and acceptance of the destination university to receive the information. Comments:
public Mona Kabiri
Clinical Research Development Unit, First Floor, Narjes building, Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3841 7403 kabirimn@mums.ac.ir Mashhad University of Medical Sciences scientific Mona Kabiri
Clinical Research Development Unit, First Floor, Narjes building, Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3841 7403 Kabirimn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with human T-cell lymphotropic virus type 1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) Conscious consent to participate in the study Aged 18 years and older 18 years no limit Both Pregnancy and lactation Diagnosis of blood diseases and blood cancers such as leukemia Consumption of quercetin in the last three months Crocin supplementation Curcumin supplementation Vitamin C supplementation Dissatisfaction with participating in the study G04.1 Human T-cell lymphotropic virus associated myelopathy Treatment - Drugs Placebo Intervention group: The enrolled patients take one 500 mg quercetin capsule daily for 12 weeks, in addition to routine treatment (gabapentin). Control group:The enrolled patients take one placebo capsule daily for 12 weeks in addition to routine treatment (gabapentin). The placebo capsule contains starch and is similar in appearance, weight and packaging to quercetin capsules. The level of Interferon-gamma cytokine. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Blood sampling and serum isolation. The level of TNF-α cytokine. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Blood sampling and serum isolation. The level of Interleukin-4 cytokine. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Blood sampling and serum isolation. Virus load rate. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Blood sampling and DNA extraction. The rate of urinary disorders by urinary disturbance score (UDS). Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Use of the Uinary Disturbance Score (UDS): This scale is the sum of 3 sub-scales, each of which measures the severity of the urinary symptom such as recurrence, incomplete bowel movements, and urinary incontinence. In each subscale, the minimum score is zero (normal) and the maximum score is 4 (severe), that is measured by a neurologist based on the patient's history. Spasticity intensity by Ashworth scale. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Use of Ashworth scale: The severity of spasticity is scored with a minimum of zero (lack of spasticity) and a maximum of 4 (limb stiffness in both flexion and extension) based on the patient history and clinical examination by a neurologist. Severity of movement disorder by Osama Motor Disability Scale. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Osama Motor Disability Scale: The severity of movement disorder is scored with a minimum of zero (normal) and a maximum of 13 (bedbound), based on the patient history and clinical examination by a neurologist. Severity of movement disorder by Motor Disability Grading. Timepoint: Beginning of the study and the end of 12 weeks. Method of measurement: Motor Disability Grading Scale: The severity of movement disorder is scored with a minimum of zero (normal) and a maximum of 10 (bedbound). This scale is a modification of the Osama scale, which is graded based on a patient history and clinical examination by a neurologist. Mashhad University of Medical Sciences Approved 2022-02-16 Ethics committee of Mashhad University of Medical Sciences Ghaem Hospital, Ahmad Abad Ave., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)