| CTRI Number |
CTRI/2024/11/076801 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| 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 yogic breathing exercise on individuals excessive sweating of the palms |
|
Scientific Title of Study
|
Evaluating The Efficacy Of Nadi shodhana and Bhramari Pranayama On Primary Palmer 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 Margaret Salam |
| Designation |
PG scholar |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Room no- 07, dept. of clinical yoga, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8197155833 |
| Fax |
|
| Email |
margaretsalam888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana K |
| Designation |
HOD, Professor, Dept. Of Clinical Yoga |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9448152915 |
| Fax |
|
| Email |
dr.archanabnys@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharada Shetty P S |
| Designation |
Assistant Professor |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Room no- 07, dept. of clinical yoga, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Room no- 07, dept. of clinical yoga, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8748971865 |
| Fax |
|
| Email |
shettysharada96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Naturopathy And Yogic Sciences, Tenkamijar, Shobhavana Campus, Moodbidri, Dakshina Kannada, Karnataka, 574225 |
|
|
Primary Sponsor
|
| Name |
Dr. Margaret Salam |
| Address |
Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri, Dakshina Kannada. |
| Type of Sponsor |
Other [Self sponser] |
|
|
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 |
| Margaret Salam |
Alvas college of Naturopathy and Yogic sciences |
Room no- 07, Yoga Department, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA |
8197155833
margaretsalam888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
control group |
no intervention |
| Intervention |
Nadi shodhana pranayama and bhramari prnayama |
Nadi shodhana and bhramari pranayama for 14 mins for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed of primary hyperhidrosis |
|
| ExclusionCriteria |
| Details |
1.Secondary hyperhidrosis
2.Recent pranayama practice within last 6 months
3.Medications affecting sweat production or ANS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Starch-iodine test |
After 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hyperhidrosis QoL |
After 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 is a medical condition characterized by the excessive production of sweat, which fails to adequately fulfill the body’s thermoregulatory requirements.
- There is a wide variation in the prevalence of PHH worldwide, ranging from as low as 0.93% to as high as 14.7% with prevalence rates in India ranging from 1.5% to 9%.
- PHH is predominant in age groups of 20-25 years
- In recent years, there has been a growing interest in investigating the potential benefits of various practices within the realm of yoga. Among this practices, pranayama has garnered special attention from the scientific community.
- Pranayama is a breathing technique that involves modulating the pace of breathing.
- Pranayama such as nadi shodhana and bhramari has an impact on ANS, with an emphasis on parasympathetic effect.
- Hyperhidrosis has been linked with over activity of sympathetic nervous system.So, pranayama could provide an effective, alternative means of reducing the symptoms of hyperhidrosis thereby enhancing affected individuals quality of life.
- The study will be conducted in an outpatient hospital set up.
- Participants will be screened after full filling inclusion and diagnostic criteria.A total of 90 participants will be recruited for the study.
- They will be randomly divided into 2 equal groups. Study group n=45 and control group n= 45. Pre assessment will be recorded for both the groups. Group A will be undergoing nadi shodhana and bhramari pranayama for 14 mins/ day for 8 weeks. Group b will be under no treatment. Post assessment will be recorded after completing 8 weeks.
- Post assessment will be done through Starch iodine test and hyperhidrosis QoL questionnaire.
|