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Clinical Trials/CTRI/2025/04/084893
CTRI/2025/04/084893Not yet recruitingPhase 1

IMMEDIATE EFFECT OF COLD WATER ENEMA ON FEVER AMONG ADULTS: A SINGLE ARM STUDY

Dr. Shradha M K1 site in 1 country45 target enrollmentStarted: April 27, 2025Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
1. Temperature

Study Overview

Brief Summary

The term ’Fever’ implies to elevated core body temperature of 38-degree Celsius or more in disease or illness. Elevated temperature is a common symptom of many diseases; it can be caused by various factors including infections [ bacteria or virus] and no infectious causes [inflammatory conditions, heat stroke, or medicine side effects]. According to Naturopathy, Fever is considered as fermentation going in the body, foreign matter enters the body and gets settled in areas of favorable environment due to the state of lowered vitality. Fever produces a retrogressive metamorphosis and creates an environment to decomposes this foreign matter and expel it. Enema includes ’cleaning out’ the lower portion of the intestine using water which helps in detoxifying the fermented morbid matter. There are several antipyretics used to decrease fever, but it has its own side effects. There is no previous study on Immediate effect of cold-water enema for fever among adults therefore the present study aims to understand the Immediate effect of cold-water enema among adults, a single arm study.

This study aims to assess the Immediate effect of cold enema on Fever among the adults on both genders of age group 18-30 years with the temperature of 38 degree Celsius or more. Total sample of 45 subjects will be given one session of cold enema. Assessment will be recorded before the treatment and post assessment will be recorded after the treatment, 5min, 15min, 30min, 45min, 1st hour, 3rd hour and 6th hour

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Patients with fever 3days or less than 3 days
  • Temperature of 38°C [100.4°F] or more
  • Age group of “18-30" yrs
  • Gender both males and females
  • Willingness to participate in the study.

Exclusion Criteria

  • 1.Females with menstrual cycle
  • Anal fissure
  • Hemorrhoids
  • Pregnancy
  • Fever with chills
  • Any Medication if they are taking.

Outcomes

Primary Outcomes

1. Temperature

Time Frame: Assessments done at two time points | 1. Pre assessment- Before intervention | 2. Post assessment - After intervention - 5mins, 15mins, 30mins, 45mins, 1st hour, 3rd hour, 6th hour.

Secondary Outcomes

  • 1. Pulse rate(2. Respiratory rate)

Investigators

Sponsor
Dr. Shradha M K
Sponsor Class
Other [Self Sponsor]
Responsible Party
Principal Investigator
Principal Investigator

DrShradha M K

Alvas College of Naturopathy and Yogic Sciences

Study Sites (1)

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