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IRCT20180618040127N1 IRCT 2018-08-22 Mashhad University of Medical Sciences 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 2018-10-02 anticipated 40 Complete https://irct.ir/trial/32494 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization on the individual level will be done using the online tools for random number generation. Then, the sequence will be placed in dark envelopes based on the order of appearance. The researcher chooses the first envelope for each new patient without disturbing the arrangement of the envelopes, Blinding description: Patients are blinded by placebo. The data analyzer is not aware of the study groups. 3 patients with HTLV-1 associated myelopathy. Intervention 1: Intervention group: daily usage of two capsules of 25 mg/kg of gluronic acid. Intervention 2: Control group: Placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Fariba Zemorshidi
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0000 zemorshidif@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Reza Boostani
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0000 Boostanir@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both Other causes of spastic paraparesis receive other drugs that affect the immune system Existence of other diseases other than HAM / TSP B97.33 Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere Treatment - Drugs Placebo Intervention group: daily usage of two capsules of 25 mg/kg of gluronic acid Control group: Placebo 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. Mashhad University of Medical Sciences Approved 2018-08-11 Ethics committee of ŁˇMashhad University of Medical Sciences Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi) Mashhad Razavi Khorasan Iran (Islamic Republic of) Approved 2018-08-11 Ethics committee of Mashhad University of Medical Sciences Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi) mashhad Razavi Khorasan Iran (Islamic Republic of)