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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210531051459N2

Enrollment

Registered

2022-04-08

Start date

2022-06-05

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human T-cell lymphotropic virus associated myelopathy. Human T-cell lymphotropic virus associated myelopathy

Interventions

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 enrolle

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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-a 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.	—

Measure

Time frame

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-a 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.

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Kabiri

Mashhad University of Medical Sciences

kabirimn@mums.ac.ir+98 51 3841 7403

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026