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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011367
Receipt No. R000013314
Scientific Title Efficacy of intravenous versus oral high-dose vitamin C on patients with postherpetic neuralgia: a prospective 4-week, randomized, open-label, controlled clinical trial.
Date of disclosure of the study information 2013/08/03
Last modified on 2014/01/11

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Basic information
Public title Efficacy of intravenous versus oral high-dose vitamin C on patients with postherpetic neuralgia: a prospective 4-week, randomized, open-label, controlled clinical trial.
Acronym effects of oral versus intravenous ascorbate.
Scientific Title Efficacy of intravenous versus oral high-dose vitamin C on patients with postherpetic neuralgia: a prospective 4-week, randomized, open-label, controlled clinical trial.
Scientific Title:Acronym effects of oral versus intravenous ascorbate.
Region
Asia(except Japan)

Condition
Condition postherpetic neuralgia
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This prospective randomized, parallel, open-label, controlled trial assessed whether intravenous ascorbate is more effective than oral ascorbate in PHN.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The changes in plasma ascorbate concentrations compared to the baseline-ascorbate concentrations after intervention
Key secondary outcomes The changes in daily average scales of spontaneous pain on the 11-point NRS measurement and the response rates after intervention

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 oral ascorbate (1000 mg/day) given for 4 weeks
Interventions/Control_2 intravenous ascorbate (3,500 mg) administered eight times within 4 weeks
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
18 years-old <
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) diagnosis of postherpetic neuralgia (PHN) criteria - having PHN for at least 3 months but no longer than 2 years after ruling out other possible polyneuropathies and having an average daily spontaneous pain rated at least score 3 on an eleven point numeric rating pain scale (11- point NRS) from 0 to 10 (with 0 being no pain at all and 10 being the worst pain imaginable); (2) age ranged from 18 to 85; (3) female patients who were non-pregnant and non-lactating.
Key exclusion criteria Patients were excluded if blood level of uric acid was higher than 7.0
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jen-Yin Chen
Organization Chi Mei Medical Center, Tainan, Taiwan
Division name Department of Anesthesiology
Zip code
Address No.901, Zhonghua Rd., Yongkang Dist., Tainan City 710, Taiwan
TEL 886-6-2812811
Email 900316@mail.chimei.org.tw

Public contact
Name of contact person
1st name
Middle name
Last name Miao-Lin Hu
Organization National Chung Hsing University, Taichung, Taiwan
Division name Department of Food Science and Applied Biotechnology
Zip code
Address 250 Kuo-Kuang Road, Taichung, Taiwan 402
TEL 886-4-22812363
Homepage URL
Email mlhuhu@nchu.edu.tw

Sponsor
Institute Chi Mei Medical Center
Institute
Department

Funding Source
Organization the research fund of Chi Mei Medical Center (CMFHR9850), Tainan, Taiwan.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Taiwan

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 Department of Anesthesiology, Chi Mei Medical Center, Tainan, Taiwan

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 03 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
2004 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 21 Day
Last follow-up date
2005 Year 12 Month 31 Day
Date of closure to data entry
2005 Year 12 Month 31 Day
Date trial data considered complete
2005 Year 12 Month 31 Day
Date analysis concluded
2008 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 03 Day
Last modified on
2014 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013314

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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