| 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
|
|
|
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
|
|
|
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. |