Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06308367

The Therapeutic Effect of Betaine in Syringomyelia

Led by Xuanwu Hospital, Beijing · Updated on 2024-03-13

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia. Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage.

CONDITIONS

Official Title

The Therapeutic Effect of Betaine in Syringomyelia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects
  • No effective response to duraplasty and shunting treatment in the 12 months before study entry
  • Estimated life expectancy greater than 12 months
  • Ability to understand and willingness to sign informed consent, or a caregiver who can do so
  • Ability to swallow tablets
Not Eligible

You will not qualify if you...

  • Cardiometabolic disease requiring prescribed medications
  • Evidence of tumor metastasis, recurrence, or invasion
  • History of psychiatric diseases
  • History of seizures
  • History of arteriosclerotic cardiovascular diseases within 6 months
  • New York Heart Association Grade II or greater congestive heart failure
  • Serious and uncontrolled cardiac arrhythmia
  • Significant vascular disease such as moderate or severe carotid stenosis, aortic aneurysm, or aortic dissection
  • Severe infection
  • History of allergy to relevant drugs
  • Pregnancy, lactation, or fertility program in the next 12 months
  • History or current diagnosis of peripheral nerve disease
  • Abnormal liver or renal function
  • Active tuberculosis
  • Transplanted organs
  • Human immunodeficiency virus
  • Participation in other experimental studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fengzeng Jian

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

J

jian fengzeng

CONTACT

C

chenghua yuan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Therapeutic Effect of Betaine in Syringomyelia | DecenTrialz