The effect of energy water on the healing of skin lesions in patients with vitiligo
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. To prepare random blocks with variable sizes from https://www.sealedenvelope.com/simple-randomiser/v1/lists
is used.
Settings and conduct
50 new patients are randomly selected. after obtaining informed consent are placed in two groups of intervention and control. Both receive PUVA 2 sessions per week. simple and energetic water are coded by the supplier And it's divided randomly between two groups .both consume orally 1liter per day from the first day of phototherapy to the end of the third month. Demographics, The extent and severity of vitiligo in the two groups at the beginning, sixth week and end of the twelfth week are measured by VASI score and the response of the two groups is compared. In this study, the analyzer and participants are unaware of the type of water of each code.
Participants/Inclusion and exclusion criteria
Inclusion criteria: New patients with vitiligo who undergo puva phototherapy and at the same time do not receive any medications for the treatment of vitiligo will be included in the study after obtaining informed consent.
exclusion criteria: Patients who are not undergoing phototherapy or are simultaneously using another drug to treat vitiligo or who are not satisfied with attending the study.
Intervention groups
In the intervention group, patients consume 1 liter per day of cosmic energetic water for 3 months, in addition to phototherapy.
In the control group, in addition to phototherapy, they receive one liter of regular water per day in similar containers.
Main outcome variables
1. The speed of treatment of vitiligo
2. Success rate in the treatment of vitiligo
3. The amount of time spent treating vitiligo
4. The amount of money spent for the treatment of vitiligo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211219053455N1
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Masoud Khoshraftar Roudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 8413
Email address
khoshraftarm991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of energetic water on the response of lesions in vitiligo patients treating with PUVA ( a randomized clinical trial study
Public title
Assessing the effect of cosmic energetic water on vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New patients with vitiligo who receive light therapy with PUVA and at the same time do not receive another drug to treat vitiligo enter the study after obtaining informed consent
Exclusion criteria:
Patients who are treated with other drugs for vitiligo in addition to phototherapy or are unwilling to continue treatment and intervention are excluded from the intervention.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocking method: to prepare random blocks with variable sizes from the site sealedenvelope.com/simple-randomiser/v1/lists is used. The contents of each block are sealed in a closed envelope and when patients refer, one of the blocks is randomly selected and placed in one of the study arms, depending on the content of the individual. Similarly, after the completion of the first block, the second block is randomly selected and this continues until the last block and the allocation of the last person to the study arms. It is established between groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The analyst and participant will be unaware of the intervention and control groups. Both types of energy water and regular drinking water are similar in color, smell and taste and are placed in two containers A and B, which will be watered to 25 participants from container A and 25 others from container B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
4th floor, No164 ,Pars 22, Kuhsangi
City
Mashhad
Province
Razavi Khorasan
Postal code
9175734719
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.MUMS.REC.1400.281
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Healing and preventing the progression of skin lesions in patients with vitiligo
Timepoint
Before the intervention, 45 and 90 days after the start of energetic water consumption
Method of measurement
VASI score index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily oral consumption of one liter of energetic water produced by a pyramid resonator
Category
Treatment - Drugs
2
Description
Control group: Daily oral consumption of one liter of ordinary drinking water