UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011367 |
|---|---|
| Receipt number | 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 19:44:17 |
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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
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
mlhuhu@nchu.edu.tw
Sponsor or person
Institute
Chi Mei Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013314
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