跳至主要内容
临床试验/NCT06731101
NCT06731101已完成不适用

The Efficacy of Stellate Ganglion Block Versus Combined Oral Anticholinergic and Antidepressant Drugs on Treatment of Palmar Hyperhidrosis; A Randomized Comparative Study

Fayoum University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Secretions

研究概览

简要总结

The aim of the study is to compare between ganglion block versus combined oral anticholinergic and antidepressant drugs on treatment of palmar hyperhidrosis

详细描述

Palmar hyperhidrosis is a medical condition characterized by excessive sweating specifically from the palms of the hands. This condition can significantly impact an individual's quality of life, leading to social embarrassment, anxiety, and difficulties in daily activities. It is classified as a type of primary hyperhidrosis, which means it occurs without an identifiable underlying medical cause (Solish et al., 2022).

The prevalence of palmar hyperhidrosis is estimated to affect about 1% to 3% of the population. Symptoms typically begin in childhood or adolescence, often becoming more pronounced during periods of hormonal changes such as puberty. The condition may run in families, suggesting a genetic predisposition (Wadhawa et al., 2019).

The underlying mechanism involves hyperactivity of the sympathetic nervous system, particularly affecting the eccrine sweat glands located in the palms (Kisielnicka et al., 2022).

Unlike normal sweating, which primarily serves thermoregulation (cooling the body), palmar hyperhidrosis is triggered by emotional stimuli such as stress or anxiety rather than heat. This inappropriate activation leads to excessive sweating that can occur even at rest (Schote et al., 2022).

Diagnosis is primarily clinical and based on patient history and visible signs of excessive sweating. Patients often report episodes that are bilateral and symmetrical, with cold and wet palms that may appear pale or blushed. The diagnosis does not typically require extensive testing unless secondary causes are suspected (Henning et al., 2021).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 45 years.
  • Both genders.
  • Exhibiting primary palmar hyperhidrosis.

排除标准

  • 1. An inability of patient to cooperate.
  • Known allergies to anticholinergic or antidepressant drugs.

研究组 & 干预措施

Drugs

Active Comparator

librax + tryptizole

干预措施: Tryptizole + Librax (Drug)

Stellate ganglion block

Active Comparator

bupivacaine+ lidocaine + dexamethasone injection into stellate ganglion

干预措施: Bupivacaine + Lidocaine +dexamethasone (Drug)

结局指标

主要结局

Secretions

时间窗: 3 months

i.e. presence/absence of hyperhidrosis

次要结局

  • Compensatory hyperhidrosis(1 ]week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taha mohamed agmy

Atef Mohamed Mahmoud

Fayoum University

研究点 (1)

Loading locations...

相似试验