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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022106
Receipt No. 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

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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
Email 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
Email yunespanahi@yahoo.com

Sponsor
Institute Baqiyatallah University of Medical Sciences, Tehran, Iran
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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