跳至主要内容
临床试验/CTRI/2025/06/088418
CTRI/2025/06/088418尚未招募4 期

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.

Saimirra Innopharm Pvt ltd1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年6月9日最近更新:

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

发起方
Saimirra Innopharm Pvt ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Aabha Nagral

Jaslok Hospital and Research Centre

研究点 (1)

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