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CTRI Number  CTRI/2025/11/097504 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 27/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of cold foot and arm bath for controlling excessive sweating 
Scientific Title of Study   Effect of Prolonged Cold Foot and Arm Immersion in the Management of Primary Hyperhidrosis A Randomized controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Bhogi 
Designation  MD Scholar 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Alvas college of Naturopathy and Yogic Sciences Room number 09 Department of Clinical Naturopathy Moodubidrie Mangalore Taluk Dakshina Kannada

Dakshina Kannada
KARNATAKA
574225
India 
Phone  8088506113  
Fax    
Email  bhogineha123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Vanitha S Shetty 
Designation  Guide 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Alvas college of Naturopathy and Yogic Sciences Shobhavana Campus Mijar Moodubidrie Dakshina Kannada Taluk Karnataka

Dakshina Kannada
KARNATAKA
574225
India 
Phone  9008004542  
Fax    
Email  drvanithashetty16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Prajwal H M  
Designation  Assistant Professor Co - Guide 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Alvas college of Naturopathy and Yogic Sciences Room number 09 Department of Clinical Naturopathy Tenkamijar Shobhavana Campus Moodbidri

Dakshina Kannada
KARNATAKA
574225
India 
Phone  9740435261  
Fax    
Email  hmprajwal8@gmail.com  
 
Source of Monetary or Material Support  
Alvas College of Naturopathy and Yogic sciences, Mijar, Moodbidri, Dakshina Kannada, Karnataka,India - 574225 
 
Primary Sponsor  
Name  Dr. Neha Bhogi 
Address  Alvas College of Naturopathy and yogic Sciences, Shobhavana, Mijar, Moodbidri, DK, 574225 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Bhogi  Alvas College of Naturopathy and Yogic Sciences  Room number 09 Department of Clinical Naturopathy Alvas college of Naturopathy and Yogic Sciences, Moodubidrie, Mangalore Taluk, Karnataka
Dakshina Kannada
KARNATAKA 
8088506113

bhogineha123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee for human studies of Alvas College of Naturopathy and Yogic Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L745||Focal hyperhidrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Prolonged Cold Foot and Arm Immersion  Before treatment, subjects are asked to wash their hands and feet with warm water thoroughly. In a foot and arm immersion tub, the cold water with temperature of 55 - 65 degree Fahrenheit is filled approximately with the depth of three to four inches. Temperature of the water is maintained by the addition of ice into the tub. The feet and arm should be immersed in the tub for 20 minutes. During the immersion, subjects are asked to apply the friction, just by rubbing the feet and hands respectively together. After the treatment, subjects should wipe their arms and feet to prevent chillness.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hyperhidrosis Disease Severity Scale(HDSS)
Minor test - Startch Iodine Test 
Pre assessment - Day 0 before giving the intervention
Post assessment - After 30 days of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Hyperhidrosis Quality of Life Index (HidroQoL)  Baseline and after 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/05/2026 
Date of Study Completion (India) 29/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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. 

 
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