UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055637 |
|---|---|
| Receipt number | R000063581 |
| Scientific Title | Characterization and Placebo-Controlled Clinical Trials of Zinc Oxide Salve for Eczema Pruritus |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/26 18:45:18 |
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Basic information
Public title
Characterization and Clinical Trials of Petroleum Jelly for Pruritus Associated with Eczema
Acronym
CCTPJPAE
Scientific Title
Characterization and Placebo-Controlled Clinical Trials of Zinc Oxide Salve for Eczema Pruritus
Scientific Title:Acronym
CPCCTZOSEP
Region
| Asia(except Japan) |
Condition
Condition
Eczema related Pruritus
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of a Zinc Oxide salve in reducing eczema-related pruritus through placebo-controlled clinical trials. Additionally, it will investigate the salve's physical and chemical characteristics to better understand its mode of action in pruritus treatment related to eczema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Prepared salve was efficient in working
Key secondary outcomes
Prepared Salve proved beneficial in treatment of pruritus associated with ezema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Patients in Zinc Oxide Salve group received a salve containing zinc oxide mixed with petroleum jelly. The salve was designed to treat eczema-related pruritus through its anti-inflammatory and antimicrobial properties.
Interventions/Control_2
Petroleum Jelly Placebo group served as the placebo, where participants were treated with petroleum jelly only, without the active ingredient zinc oxide. Petroleum jelly was used to soothe the skin and provide moisture retention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 14 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient must have eczema
Key exclusion criteria
Exclusion crietera involves, Skin infection , Diabetes, Cardiac Diseases, Allergies
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Dibaj |
| Middle name | Azhar |
| Last name | Bhatti |
Organization
University of Engineering and Technology
Division name
Lahore, Pakistan
Zip code
05499
Address
Lahore, Pakisan
TEL
03214529967
debajazhar@gmail.com
Public contact
Name of contact person
| 1st name | Dibaj |
| Middle name | Azhar |
| Last name | Bhatti |
Organization
University of Engineering and Technology
Division name
Lahore, Pakistan
Zip code
05499
Address
Lahore, Pakisan
TEL
03214529967
Homepage URL
debajazhar@gmail.com
Sponsor or person
Institute
University of Engineering and Technology, Lahore, Pakistan
Institute
Department
Personal name
Dibaj Azhar Bhatti
Funding Source
Organization
No organization is funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Chemistry, University of Engineering and Technology
Address
Lahore, Pakistan
Tel
03466990990
arjumand@uet.edu.pk
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-M.Phol-App-Chem-26
Org. issuing International ID_1
University of Engineering and Technology, Lahore
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University Health Clinic, University of Engineering and Technology, Lahore
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
For Day 0, the t-tests showed statistical significance with p-values of 0.033. While days 3 and 7 showed p-values < 0.0001.
Results date posted
| 2024 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Consent forms were made
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063581
