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CTRI Number  CTRI/2025/03/082674 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   to see effect of sheetali pranayama on sweating tendency  
Scientific Title of Study   A study to assess the efficacy of sheetali pranayama on swed pravruti in degree college students having different sharir prakruti 
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 Akashata Balasaheb Khatke 
Designation  PG Scholar (Kriya Sharir) 
Affiliation  D Y Patil University School of Ayurveda 
Address  Department of Kriya Sharir,D Y Patil School of Ayurveda Deemed to be university,Nerul, Navi Mumbai,Thane

Thane
MAHARASHTRA
400706
India 
Phone  8422090879  
Fax    
Email  akashata.khatke@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shruti Phatak  
Designation  Professor 
Affiliation  D Y Patil University School of Ayurveda 
Address  Department of Kriya Sharir,D Y Patil School of Ayurveda Deemed to be university,Nerul, Navi Mumbai,Thane

Thane
MAHARASHTRA
400706
India 
Phone  9821750582  
Fax    
Email  shruti.phatak@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shruti Phatak  
Designation  Professor 
Affiliation  D Y Patil University School of Ayurveda 
Address  Department of Kriya Sharir,D Y Patil School of Ayurveda Deemed to be university,Nerul, Navi Mumbai,Thane

Thane
MAHARASHTRA
400706
India 
Phone  9821750582  
Fax    
Email  shruti.phatak@dypatil.edu  
 
Source of Monetary or Material Support  
DY Patil Deemed to be university School of Ayurveda, Nerul, Navi mumbai-400706,India 
 
Primary Sponsor  
Name  D Y Patil School of Ayurveda Deemed to be University Nerul, Navi Mumbai 
Address  D Y Patil School of Ayurveda Deemed to be University Nerul, Navi Mumbai 400706, India 
Type of Sponsor  Research institution and hospital 
 
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 
DrAkashata Khatke  D Y Patil School of Ayurveda  D Y Patil school of ayurveda, Kriya Sharir Department,DY Patil Deemed to be University ,Nerul,Navi Mumbai,Thane Maharashtra India
Thane
MAHARASHTRA 
08422090879

akashata.khatke@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of D Y Patil Deemed to be University,School of Ayurveda,Nerul, Navi Mumbai,Thane  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  College students Age-18-25 years 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Sheetali pranayama (Procedure Reference: , Procedure details: total 30 students will be enrolled after screening informed consents will be taken assessment of prakruti will be done using a validated questionaire by K.Patwardhan & R.Sharma Assessment of sweating will be done using a validated questionaire As sweating is being examined so both heat seasons will be considered subjects will be instructed to perform sheetali pranayama in the morning for 15rounds for 8 weeks reassement of sweating will be done using a questionaire efficacy of sheetali pranayama on swed pravruti wwill be assessed)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Community-Indian
Subjects ready to abide by trail procedure and to give informed consent
Students categorized in moderate (23-46) and severe (46-69) groups 
 
ExclusionCriteria 
Details  Subjects having any acute or chronic nervous system disorder or hormonal imbalance that could influence body temperature and thermoregulation.
Taking medications or using other wellness strategies that could metabolism and energy expenditure.
Students who are doing pranayama regularly. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There is significant role of sheetali pranayama on swed pravruti.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Formulation of questionnaire to assess swed pravruti   Season 1 - Greeshma (summer) - before & after
Season 2 - Sharad (autumn)- before & after 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Summary:
The fundamental concept of human physiology in Ayurveda revolves around the concept of Dosha, Dhatu and Mala. These three have been considered as root for the sustainance and homeostasis of the body.Dosha are the biological entity governing and regulating all the physiological functions of the body, Dhatu are the major tissues of the body while Mala refers to the excretory products of the digestion and metabolism. All the vitiated Dosha, Dhatu
are said to be Mala and considered as the primary causative factor of all diseases.All these Mala can be classified into two types i.e. Aahara Mala and Dhatu Mala.Aahara Mala are Mutra (urine),Purisha (faeces) and Sweda (sweat) while Dhatu Mala are Kapha, Pitta, Khamala, Sweda,Keshaloma, Sneha of eyes and skin for Rasadi Dhatu respectively. Sweda is carried away via Swedavaha Srotas, plays an important role in excretion of waste metabolites produced during digestion and metabolism and temperature regulation along with Pitta. But excessive sweating gives rise to bad odour of the skin and itching. Hyperhydrosis causes excess moisture over skin leading to bacterial and fungal infection resulting in itching. Besides this, burning sensation in the body, aggravation of Pitta, fainting (Murchha), heaviness of the body, pain in joints,Visphota (blisters), Bhrama (giddiness), Klama (tiredness), vomiting, Trishna (thirst), Rakta Dushti Lakshana (features of vitiated blood ) etc. are the features of excessive sweating.These characteristics are same as in dehydrated state of body due to excess water and mineral loss owing to excessive sweating. Also they experience substantial impairments in terms of the social and professional environments because of increased sweat production. Two pranayamas i.e. Sheetali and Sitkari pranayama have been described by ancient yoga texts as having the potential to give a cooling effect on the body and also to reduce thirst sensation. This pranayama is especially important during the summer months when many people feel restless due to the intense heat. It removes the hot air from our body and enters the cold air in, due to which heat is released from our body and the whole body becomes cold.

This research study aims to investigate the efficacy of Sheetali Pranayama specifically on sweda pravruti in college-going students. Furthermore, it seeks to explore the influence of different Prakruti, which refers to an individual’s unique mind-body constitution according to Ayurveda.The growing interest in holistic approaches to sweat management necessitates the investigation of Sheetali Pranayama's efficacy on sweda pravruti in college students. By considering different Prakruti and conducting a scientific study, we can contribute to the existing body of knowledge on natural interventions for sweat management and promote the well-being of college students.


 
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