A double-blind Randomized control trial to study the efficacy of combination of Taurine and L-Carnitine in alleviating muscle cramps in patients with liver cirrhosis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The objective of this study is to evaluate the efficacy of L-Carnitine and Taurine supplementation in reducing the frequency, severity, and duration of muscle cramps in patients with liver cirrhosis.
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of a combination of L-Carnitine (1g) and Taurine (3g) in alleviating muscle cramps in patients with liver cirrhosis. Muscle cramps are a common yet often overlooked complication in liver cirrhosis, significantly impacting patients’ quality of life.
Objectives: Primary Objective: To assess the effectiveness of L-Carnitine and Taurine in reducing the frequency, severity, and duration of muscle cramps in cirrhotic patients.Study Design:Population: 70 participants (35 in each group) aged 18–75 years with liver cirrhosis and experiencing at least 3 muscle cramps per week.Randomization: Participants will be randomly assigned to two groups:Group A: Receives L-Carnitine and Taurine combination as a sachet mixed with water daily for 3 months.Group B: Receives a placebo sachet daily for 3 months.Blinding: Double-blind design, ensuring both participants and investigators are unaware of group assignments.Key Measurements:Participants will maintain a symptom diary to record the frequency and duration of muscle cramps.The severity of cramps will be assessed using the Visual Analogue Scale (VAS).Follow-ups will be conducted monthly (via video and in-person consultations).Inclusion and Exclusion Criteria:Inclusion: Adults with liver cirrhosis experiencing frequent muscle cramps and willing to comply with study procedures.Exclusion: Patients with allergies to the study drugs, alcohol use in the past 3 months, or conditions like uncontrolled hepatic encephalopathy or chronic kidney disease.Expected Outcomes:This trial aims to demonstrate that the combination of L-Carnitine and Taurine is effective and safe for reducing muscle cramps in cirrhotic patients, potentially improving their overall well-being and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Cirrhotic patients with muscle cramps frequency more than or equal to 3 times a week at rest or during sleep.
- •Willing to provide informed consent and comply with study procedures.
排除标准
- •Patients with known allergies to taurine or L-carnitine.
- •No alcohol or IV drug use for the last 3 months.
- •Blood glucose level more than 270mg/dl at the time of enrolment.
- •Patients currently taking muscle relaxants or other supplements that might interfere with the study results.
- •Pregnant or breastfeeding women.
- •Patients with CKD.
- •Patients with uncontrolled hepatic encephalopathy History of Peripheral neuropathy, Thyroid disease, Pulmonary hypertension, Cardiac disease.
结局指标
主要结局
The objective of this study is to evaluate the efficacy of L-Carnitine and Taurine supplementation in reducing the frequency, severity, and duration of muscle cramps in patients with liver cirrhosis.
时间窗: Each patient from each of the 3 groups shall be followed up a total of 3 times: | At 1st month: Via video consultation | At 2nd month: Via video consultation | At 3rd month: By physical consultation in OPD
次要结局
未报告次要终点
研究者
Dr Aabha Nagral
Jaslok Hospital and Research Centre
