UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022106 |
|---|---|
| Receipt number | R000025483 |
| Scientific Title | Adjunctive therapy with curcumin for peptic ulcer: A randomized controlled trial |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/04/27 16:45:42 |
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Basic information
Public title
Adjunctive therapy with curcumin for peptic ulcer: A randomized controlled trial
Acronym
Curcumin supplementation for peptic ulcer
Scientific Title
Adjunctive therapy with curcumin for peptic ulcer: A randomized controlled trial
Scientific Title:Acronym
Curcumin supplementation for peptic ulcer
Region
| Asia(except Japan) |
Condition
Condition
Peptic ulcer disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of curcumin on clinical symptoms of peptic ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in the frequency and severity of peptic ulcer symptoms following curcumin supplementation for 14 days
Key secondary outcomes
Effect of curcumin supplementation (for 14 days) on the eradication of Helicobacter pylori
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment group:
Curcumin (500 mg/day) + piperine (5 mg/day) + standard anti-helicobacter triple therapy
Treatment duration: 14 days
Interventions/Control_2
Control group:
Placebo (microcrystalline cellulose) + 5 mg piperine + standard anti-helicobacter triple therapy
Treatment duration: 14 days
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diagnosis of clean-based gastric or duodenal ulcers in gastroscopy and presence of H. pylori infection based on the rapid urease test on the biopsy specimens of antral mucosa
Key exclusion criteria
History of receiving anti-helicobacter treatment, concomitant treatment with corticosteroids, chronic diseases, malignanices including gastric malignancy, and lack of adherence to the study protocol defined as non-compliance with the administered anti-helicobacter triple therapy, or changing the triple therapy regimen
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yunes Panahi |
Organization
Baqiyatallah university of Medical Sciences, Tehran, Iran
Division name
Chemical Injuries Research Center
Zip code
Address
Molla-Sadra st.
TEL
+982188211524
yunespanahi@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yunes Panahi |
Organization
Baqiyatallah university of Medical Sciences, Tehran, Iran
Division name
Chemical Injuries Research Center
Zip code
Address
Molla-Sadra st.
TEL
+982188211524
Homepage URL
yunespanahi@yahoo.com
Sponsor or person
Institute
Baqiyatallah University of Medical Sciences, Tehran, Iran
Institute
Department
Personal name
Funding Source
Organization
Baqiyatallah University of Medical Sciences, Tehran, Iran
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
Address
Tel
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
Baqiyatallah University of Medical Sciences, Tehran, Iran
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025483
