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临床试验/CTRI/2025/08/092576
CTRI/2025/08/092576
尚未招募
1 期

A Pilot Randomized Controlled Trial to Evaluate the Effectiveness of a Low Carbohydrate High Fat Diet on Tremor Severity and Mental Health Outcomes in Patients with Essential Tremor

Self funded1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月18日最近更新:

概览

阶段
1 期
状态
尚未招募
发起方
Self funded
入组人数
50
试验地点
1
主要终点
Change in tremor severity using Fahn-Tolosa-Marin Tremor Rating Scale

概览

简要总结

This pilot study evaluates the effectiveness of a Low Carbohydrate High Fat LCHF diet also known as the ketogenic diet on tremor severity anxiety depression and quality of life in patients with Essential Tremor ET

Essential Tremor is a common neurological disorder that causes involuntary shaking especially in older adults Current treatments including medications and surgery have several limitations This has led to growing interest in noninvasive alternatives

The LCHF diet is known for its neuroprotective and antiinflammatory effects in neurological conditions such as epilepsy and Parkinson disease It is believed to influence neurotransmitters like GABA which play a role in the development of Essential Tremor

This study is conducted at GIPMER New Delhi and involves 50 adult ET patients Participants are randomly assigned to either a structured LCHF diet or standard care for a period of six weeks Assessments are conducted at the beginning and end of the study using validated tools Fahn Tolosa Marin Scale for tremor Hospital Anxiety and Depression Scale HADS and Quality of Life in Essential Tremor Questionnaire QUEST

Weekly followups are included to monitor diet adherence safety and side effects The study is ethically sound and low risk with minor side effects like nausea and fatigue being anticipated The design is prospective randomized and uses appropriate statistical methods for analysis

If effective the findings could support larger trials and promote dietary strategies as a safe and accessible treatment for patients with Essential Tremor

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of Essential Tremor Age above 18 years Willingness to follow LCHF dietary plan Able to provide informed consent Not currently on any specific diet.

排除标准

  • Age less than 18 years Pregnancy or breastfeeding History of diabetes, liver or kidney disease History of pancreatitis or gallstones Severe psychiatric illness Currently following an LCHF or ketogenic diet • Participation in another clinical trial.

结局指标

主要结局

Change in tremor severity using Fahn-Tolosa-Marin Tremor Rating Scale

时间窗: Baseline and 6 weeks

次要结局

  • Change in anxiety and depression scores using HADS(Baseline and 6 weeks)
  • Change in quality of life using QUEST(Baseline and 6 weeks)

研究者

发起方
Self funded
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sujata Roshan

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research GIPMER

研究点 (1)

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