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GB34 Acupuncture in Acute Cholecystitis

2021年7月14日 更新者:Alirıza Erdoğan、Nigde Omer Halisdemir University

GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis

The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.

研究概览

地位

招聘中

详细说明

Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain.

Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients.

In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.

研究类型

介入性

注册 (预期的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Niğde、火鸡
        • 招聘中
        • Niğde Ömer Halisdemir University Training and Research Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosed and hospitalised patients with mild acute cholecystitis

Exclusion Criteria:

  • Pregnant women
  • Immunosuppressive patients
  • Patients with intermediate and severe acute cholecystitis
  • Patients with acalculous acute cholecystitis
  • Patients with uncontrolled diabetes mellitus
  • Patients with collegen tissue diseases
  • Patients with malignancies
  • Patients who are using anti-coagulant or anti-aggregant medications
  • Patients with blood diseases
  • Patients with BMI>35

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Acupuncture
GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.
无干预:Controls
Patients will only receive standard medical treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Perceived pain
大体时间:Through study completion, an average of 1 year
Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient.
Through study completion, an average of 1 year
Guarding
大体时间:Through study completion, an average of 1 year
presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease.
Through study completion, an average of 1 year
Rebound
大体时间:Through study completion, an average of 1 year
presence or absence of abdominal rebound assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
Through study completion, an average of 1 year
Hb
大体时间:Through study completion, an average of 1 year
Hemoglobin values expressed as g/dL
Through study completion, an average of 1 year
WBC
大体时间:Through study completion, an average of 1 year
White blood cell count in microliter
Through study completion, an average of 1 year
NEU%
大体时间:Through study completion, an average of 1 year
percent of neutrophils
Through study completion, an average of 1 year
LYM%
大体时间:Through study completion, an average of 1 year
percent of lymphocytes
Through study completion, an average of 1 year
PLT
大体时间:Through study completion, an average of 1 year
platelet count in microliter
Through study completion, an average of 1 year
CRP
大体时间:Through study completion, an average of 1 year
C-reactive protein levels expressed in mg/L
Through study completion, an average of 1 year
AST
大体时间:Through study completion, an average of 1 year
Aspartate aminotransferase levels expressed in IU/L
Through study completion, an average of 1 year
ALT
大体时间:Through study completion, an average of 1 year
Alanine aminotransferase levels expressed in U/L
Through study completion, an average of 1 year
ALP
大体时间:Through study completion, an average of 1 year
Alkaline phosphatase levels expressed in U/L
Through study completion, an average of 1 year
GGT
大体时间:Through study completion, an average of 1 year
Gamma glutamyl transferase levels expressed in U/L
Through study completion, an average of 1 year
Amylase
大体时间:Through study completion, an average of 1 year
Amylase levels expressed in U/L
Through study completion, an average of 1 year
Total bilirubin
大体时间:Through study completion, an average of 1 year
Total bilirubin levels expressed in mg/dL
Through study completion, an average of 1 year
Direct bilirubin
大体时间:Through study completion, an average of 1 year
Direct bilirubin levels expressed in mg/dL
Through study completion, an average of 1 year
Oral intake
大体时间:Through study completion, an average of 1 year
if patients tolerate oral intake or not
Through study completion, an average of 1 year
Analgesic dosage
大体时间:Through study completion, an average of 1 year
Total dosage of analgesic administered in mg
Through study completion, an average of 1 year
Antibiotic dosage
大体时间:Through study completion, an average of 1 year
Total dosage of antibiotic administered in mg
Through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alirıza Erdoğan, MD、Nigde Omer Halisdemir University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月1日

初级完成 (预期的)

2022年7月1日

研究完成 (预期的)

2022年7月1日

研究注册日期

首次提交

2021年7月6日

首先提交符合 QC 标准的

2021年7月10日

首次发布 (实际的)

2021年7月13日

研究记录更新

最后更新发布 (实际的)

2021年7月21日

上次提交的符合 QC 标准的更新

2021年7月14日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 08.06.2021/32

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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