Evaluation of the effects of Gluronic acid in HTLV-1 patients

Evaluation of the therapeutic effect of Gluronic acid in HTLV-1 patients and its effect on viral and inflammatory factors

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180618040127N1

Enrollment

Registered

2018-08-22

Start date

2018-10-02

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

patients with HTLV-1 associated myelopathy. Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: daily usage of two capsules of 25 mg/kg of gluronic acid. Intervention 2: Control group: Placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HTLV-1 positive serology Symptoms of spastic paraparesis Presence of anti-HTLV-1 antibody in the cerebrospinal fluid MDG less than 9 Passing less than 15 years from incidence of disease symptoms Patient informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Other causes of spastic paraparesis receive other drugs that affect the immune system Existence of other diseases other than HAM / TSP

Design outcomes

Primary

Measure	Time frame
Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Spastisite score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination and history.;Serum level of inflammatory cytokines (IL-1, IL-6, IL-8 and TNF-a), Proviral load levels. Timepoint: At the begging of study and 12 weeks later. Method of measurement: serum level evaluation.	—

Measure

Time frame

Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Spastisite score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination and history.;Serum level of inflammatory cytokines (IL-1, IL-6, IL-8 and TNF-a), Proviral load levels. Timepoint: At the begging of study and 12 weeks later. Method of measurement: serum level evaluation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fariba Zemorshidi

Mashhad University of Medical Sciences

zemorshidif@mums.ac.ir+98 51 3840 0000

Outcome results

None listed

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