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Clinical Trials/CTRI/2025/03/082581
CTRI/2025/03/082581Not yet recruitingPhase 1

Immediate Effect Of Cold And Neutral Douche Over Thoracic Region On Pulmonary Function Among Healthy Volunteers: A Randomized Trial

Dr Rakshitha K1 site in 1 country76 target enrollmentStarted: May 12, 2025Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
76
Locations
1
Primary Endpoint
Forced vital capacity (FVC)

Study Overview

Brief Summary

Naturopathy is a unique kind of primary care that combines modern research and scientific advancements with age-old healing practices. Fasting therapy, food therapy, hydrotherapy, massage therapy, mud therapy, chromotherapy, and air therapy are examples of non-invasive treatments.

Respiratory illness is linked to Autonomic nervous system (ANS) imbalance. Two possible presentations of asthma include imbalances between the parasympathetic and sympathetic nervous systems (PNS and SNS), or hyperfunction of the PNS in the airways. Numerous naturopathic treatments can be used to balance the autonomic nerve system. The number of people with chronic respiratory diseases globally in 2017 was 544·9 million (95% uncertainty range), which was a 39·8% rise from 1990.Localized douches can be utilized to treat illnesses of the respiratory system. Early hydrotherapy textbooks discuss how a brief cold application can aid to enhance lung function. Currently only one evidence is published on neutral douche, and no evidence of the effects of cold douche is currently available. Therefore, understanding how cold douche affects thoracic rebound in pulmonary function will be aided by this research. This will help to enhance the efficacy of hydrotherapeutic techniques.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 30.00 Year(s) (—)

Inclusion Criteria

  • Age ranging from 18 to 30 years Subjects Who Are Willing To Participate In The Study Gender: Both Male And Female.

Exclusion Criteria

  • Weak And Debilitating Individuals Any Systemic Illness Subjects With Open Wounds Subjects Who Are Intolerant To Cold.

Outcomes

Primary Outcomes

Forced vital capacity (FVC)

Time Frame: Pre, Post

Forced expiratory volume at 1 second (FEV1)

Time Frame: Pre, Post

Forced expiratory flow (FEF25-75%)

Time Frame: Pre, Post

Peak expiratory flow (PEF)

Time Frame: Pre, Post

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Rakshitha K
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rakshitha K

Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire

Study Sites (1)

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