UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002804
Receipt No. R000003411
Scientific Title Effectiveness of citric acid in treating nocturnal muscle cramps: a randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2009/12/01
Last modified on 2009/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of citric acid in treating nocturnal muscle cramps: a randomized, double-blind, placebo-controlled trial
Acronym Effectiveness of citric acid in muscle cramps
Scientific Title Effectiveness of citric acid in treating nocturnal muscle cramps: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym Effectiveness of citric acid in muscle cramps
Region
Japan

Condition
Condition Nocturnal muscle cramps
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish efficacy and safety of citric acid use for the treatment of nocturnal leg muscle cramp.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of nocturnal leg muscle cramps
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Citric acid for 30 days -> (washout period for 14 days) -> Placebo for 30 days
Interventions/Control_2 Placebo for 30 days -> (washout period for 14 days) -> Citric acid for 30 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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Experiencing nocturnal muscle cramps more than two times a week
Key exclusion criteria (1)Those who have diseases that are known to cause muscle cramps: anemia, diabetes mellitus, liver disease, kidney disease, and thyroid disease
(2)Those who are taking medications that are known to cause muscle cramps (beta-stimulants,diuretics, HMG-CoA reductase inhibitors, cimetidine, lithium,morphine, nifedipine,penicillamine,and steroids)
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayumi Tanaka, MD,PhD,MPH
Organization St.Luke's International Hospital
Division name General Internal Medicine
Zip code
Address 9-1, Akashi-Cho, Chuoh Ward, Tokyo 104-8560, Japan
TEL 03-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi TanakaMD,PhD,MPH
Organization St.Luke's International Hospital
Division name General Internal Medicine
Zip code
Address 9-1, Akashi-Cho, Chuoh Ward, Tokyo 104-8560, Japan
TEL 03-3541-5151
Homepage URL
Email mytanaka@luke.or.jp

Sponsor
Institute St.Luke's International Hospital
Institute
Department

Funding Source
Organization St.Luke's Life Science Institute
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 聖路加国際病院  St.Luke's International Hospital

Other administrative information
Date of disclosure of the study information
2009 Year 12 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 No longer recruiting
Date of protocol fixation
2008 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 27 Day
Last modified on
2009 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.