UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047319 |
|---|---|
| Receipt number | R000053973 |
| Scientific Title | Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/30 01:14:34 |
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Basic information
Public title
Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection
Acronym
Wheat bran enema in infants with Lower respiratory tract infection
Scientific Title
Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection
Scientific Title:Acronym
Wheat bran enema in infants with Lower respiratory tract infection
Region
| Africa |
Condition
Condition
Lower respiratory tract infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the impact of wheat bran enema as adjuvant therapy on oxidative stress and inflammatory and anti-inflammatory cytokine in the pediatric patients with lower RTI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the impact of wheat bran enema as adjuvant therapy on oxidative stress and inflammatory and anti-inflammatory cytokine in paediatric patient with lower RTI.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
the first group includes 20 patients who will receive conventional treatment only
Interventions/Control_2
The second group includes 20 patients who will receive conventional treatment and wheat bran enema
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
| 1 | months-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients>1 month and up to 3 years, diagnosed with lower respiratory tract infection admitted to Children Hospital, Faculty of Medicine, Assiut University during the study period
Key exclusion criteria
Patients age less than one month and more than three years
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Assiut University
Division name
Pediatric department
Zip code
71515
Address
Assiut University
TEL
+20882368373
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Assiut University
Division name
Pediatric department
Zip code
71515
Address
Assiut University
TEL
+20882368373
Homepage URL
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Assiut university
Asyut Egypt
Institute
Department
Personal name
Funding Source
Organization
Assiut university
Asyut Egypt
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Egyptian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Assiut university Asyut Egypt
Address
Assiut university Asyut Egypt
Tel
+20882368373
Asmaa.zahran@aun.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
Results
Results date posted
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053973
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| Registered date | File name |
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| Registered date | File name |
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