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临床试验/CTRI/2025/11/097504
CTRI/2025/11/097504尚未招募2/3 期

Effect of Prolonged Cold Foot and Arm Immersion in the Management of Primary Hyperhidrosis A Randomized controlled Trial

Dr. Neha Bhogi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月14日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Hyperhidrosis Disease Severity Scale(HDSS)

研究概览

简要总结

Hyperhidrosis (HH) is a disorder of autonomic nervous system, characterized by excessive sweating that is brought on by an overactive sympathetic nervous system. HH is classified as either focal or general based on the distribution of the affected tissues. The scalp, the axilla, the genitalia, the palmar region of the hands, and the plantar surface of the feet are the regions most frequently impacted by this disorder because they have the highest density of eccrine and apoeccrine sweat glands. Hyperhidrosis is classified as Primary and Secondary. Primary hyperhidrosis, average age of onset is 25 years. The earliest average onset of palmar and axillary hyperhidrosis is 19 years. The mainstay of treatment is pharmacological  which includes topical application of aluminium chloride , iontophoresis , antiperspirants , anticholinergics and clonidine or surgical intervention like thoracic sympathetic surgery and botulinum toxin injections , although both are invasive and have a number of negative side effects. Cold foot and arm immersion given for 20 minutes at temperature of 55o - 65o F, on alternate days, weekly thrice for 30 days  reduces perspiration by inhibiting the glandular activity of skin through reflex phenomenon and also decreasing the stimulation of sympathetic nerves. Thus the present study aims at understanding the effect of cold foot and arm immersion for  primary hyperhidrosis depending on the severity and quality of life as it has no side effects compared to other treatment modalities. The Hyperhidrosis Disease Severity Scale, Hyperhidrosis Quality of Life Index, MINOR TEST - (Starch -Iodine) assessments were taken on baseline and after 30 days.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Subjects with Primary Hyperhidrosis Excessive sweating on axilla, palms, soles and face Sweating should last at least for 7 days HDSS Score more than 2 Subject willing to participate in the study by giving a signed informed consent.

排除标准

  • Subjects with secondary hyperhidrosis HDSS Score less than 2 Subjects under systemic medications such as anti- cholinergic, anti.
  • thyroid drugs, tropical application. subjects with low back pain Subjects consuming alcohol and smoking.

结局指标

主要结局

Hyperhidrosis Disease Severity Scale(HDSS)

时间窗: Pre assessment - Day 0 before giving the intervention | Post assessment - After 30 days of intervention

Minor test - Startch Iodine Test

时间窗: Pre assessment - Day 0 before giving the intervention | Post assessment - After 30 days of intervention

次要结局

  • Hyperhidrosis Quality of Life Index (HidroQoL)(Baseline and after 30 days)

研究者

发起方
Dr. Neha Bhogi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Neha Bhogi

Alvas College of Naturopathy and Yogic Sciences

研究点 (1)

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