ChiCTR2100049126已完成Unknown
Efficacy of Thiamine in Patients with Clinically Suspected Dry Beriberi: An Open Labeled Hospital Based Study in Bangladesh
self funding1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年7月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Clinical Improvement
研究概览
简要总结
General objective: To evaluate the efficacy of Thiamine in patients with suspected / possible dry beriberi Specific objectives:
- To describe the socio-demographic profile of patients;
- To categorize the patients according to their presenting symptoms and signs;
- To assess and compare pre and post treatment neurological features.
研究设计
- 研究类型
- Interventional
- 主要目的
- 单臂
- 盲法
- N/a
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Any person admitted to CMCH as a Suspected/Possible dry-beriberi.
- •Risk factors + at least 2 of the following signs:
- •Risk factors include Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, GIT surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic. diuretics use, renal dialysis, total parenteral nutrition.
- •Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale);
- •Positive sensory symptoms (burning, tingling or pain);
- •Objective sensory deficit (pain, touch, position, vibration sense);
- •Absent or reduced deep tendon reflexes;
- •Positive squat test (unable to rise after squatting without help);6) Leg swelling;
- •Aged 18 years and above.
排除标准
- •Patients with isolated cardiac/wet beriberi;
- •Patient with known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), drugs (e.g. INH, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) Toxin (As ,OPC, Pb ,Hg except alcohol) etc.;
- •Patients refuse to participate.
研究组 & 干预措施
Case series
Thiamine (intravenous and oral)
结局指标
主要结局
Clinical Improvement
时间窗: before treatment and After 1 week, 6 week & 12 week of treatment by Thiamine
次要结局
未报告次要终点
研究者
研究点 (1)
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