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

The assessment of quercetin drug on inflammatory cytokines and clinical signs of patients with human T-cell lymphotropic virus type 1-associated myelopathy/tropical spastic paraparesis (HAM/TSP)

Randomized clinical trial of placebo group, with parallel groups, double-blind, phase 3 on 40 patients. The www.sealedenvelope.com was used to generate a blocked random allocation sequence.

In this randomized clinical trial study, patients with tropical spastic myelopathy/paraparesis caused by human type 1 lymphotropic T virus (HAM / TSP) referred to Ghaem Hospital in Mashhad are randomly assigned to one of the two intervention or placebo groups after obtaining informed consent. Double-blind randomization will be done by packets in the package. Based on a pre-designed checklist, patients in both groups will be evaluated for 12 weeks, with clinical signs, interferon-gamma, TNF-α, and IL-4 cytokine levels, as well as virus loading at the baseline (day 1), and the end-point (end of 12 weeks).

Inclusion criteria: 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 Exclusion criteria: Pregnancy and lactation Diagnosis of blood diseases and blood cancers such as leukemia Dissatisfaction with participating in the study

In the intervention group, patients take one quercetin 500 mg capsule daily for 12 weeks in addition to routine treatment (taking gabapentin).

Interferon-gamma cytokine level, TNF-α cytokine level, IL-4 cytokine level and viral load, as well as patients' clinical symptoms such as lower extremity weakness and urinary disorders at the beginning (first day) and end of follow-up (end of 12 weeks)

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.

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.

Potential data can be shared after participants are not identified.

Access period will be started 9 months after the published results.

The data will be available to researchers working in academic and scientific institutions.

The use of data and its analysis is allowed by mentioning the source.

It is necessary to send an email to the corresponding author of the article for receiving the data.

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.