Placebo Development and Validation for Healing Water

University of Pecs

Status: Completed

Conditions: Balneology

Treatments: Other: Placebo treatment (colored tap water); Other: Colored healing water

Study type: Interventional

Funder types: Other

Identifiers

NCT04290143

OTKA_131531_PLACEBO

Details and patient eligibility

About

The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Full description

Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.

Target patient number:174

Enrollment: 174 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• willingness to participate in the study
• age between 18-80 years

Exclusion criteria

• patients physically unable to enter or exit the bath tub
• autoimmune diseases
• any kind of malignity
• acute inflammation
• infection
• acute coronary syndrome or recent surgical interventions (6 month before enrollment)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 2 patient groups, including a placebo group

Colored healing water

Active Comparator group

Description:

Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed.

Treatment:

Other: Placebo treatment (colored tap water)

Other: Colored healing water

Placebo - Colored tap water

Placebo Comparator group

Description:

Colored tap water. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. A single 20 minutes-long treatment will be performed.

Treatment:

Other: Placebo treatment (colored tap water)

Other: Colored healing water