| 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 |
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Public Title of Study
|
to see effect of sheetali pranayama on sweating tendency |
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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 |
|
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Source of Monetary or Material Support
|
| DY Patil Deemed to be university School of Ayurveda, Nerul, Navi mumbai-400706,India |
|
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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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College students Age-18-25 years |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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)
|
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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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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
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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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