UMIN-CTR Clinical Trial

Public title

A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis

Acronym

A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis
(CSP-LD03)

Scientific Title

A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis

Scientific Title:Acronym

A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis
(CSP-LD03)

Region

Japan

Condition

Interstitial cystitis

Classification by specialty

Nephrology	Infectious disease	Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine whether hydrogen dissolution water is better than normal water(placebo) for symptom improvement in patients with interstitial cystitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II,III

Primary outcomes

The proportion of the patients who has been assessed "success" at the end of the intervention

Key secondary outcomes

1) Changes of the Symptom Score in Interstitial Cystitis Symptom Index(ICSI)
2) Changes of the Problem Score in Interstitial Cystitis Problem Index(ICPI)
3) An Average frequency of urination per day
4) An Average voided volume at a time
5) Degree of urge to urinate; PUF symptom score
6) Degree of bladder pain
7) Impression by patients with GRA (Global Response Assessment)
8) Urine Test; 8-OHdG in urine
9) Adverse Events (we cannot deny the association between the food and the event)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).
After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.
And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

Interventions/Control_2

The patients will be intervened with normal water (placebo group) 200ml every three times in a day in 2 months (56days)
After that, the patients in placebo water group will be given hydrogen water for more 1 month.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients who are able to give written informed consent
2) Patients who has the characteristic finding under hydraulic distension of the bladder in interstitial cystitis by cystoscope
3) It has taken more than 12 weeks after patients took the hydraulic distension of the bladder, and symptom of patients are in stable.
4) More than 7 marks in total of Interstitial Cystitis Score in registration
5) More than 4 marks in Q4 (degree of bladder pain) in Interstitial Symptom Score
6) Age is over 20 years and less than 80 years
7) Patients are able to do the following things in this trial; getting good compliance with intaking investigating food and coming to hospital, and writing the diary and the questionnaire accurately by themselves

Key exclusion criteria

1) More than 200ml of an average voided volume at a time before the registration
2) Patients with active infection of urinary tract
3) Patients with bacterial cystitis within 12 weeks before registration
4) Patients with vaginosis
5) Patients with calculus of lower urinary tract or urethral diverticulum
6) Patients with nephrosis syndrome
7) Patients with active genital herpes
8) Patients who have operated the surgery in pelvis or its circumference and it has not taken more than 24 hours after the surgery
9) Patients with cerebrospinal disease
10) Patients with the follow disease or suspected disease; neurogenic bladder, cystitis radiation, tuberculous cystitis, cystitis with BCG, drug associated cystitis
11) Start, stop, or change of the dose of the following drugs within 4 weeks after the registration;
(a) Antiphlogistic analgetic
(b) Antidepressant
(c) Anticholinergic drug
(d) Antihistamine drug
(e) Ataractic drug
(f) Drug treatment for frequent urination and acraturesis
(g) Steroid drug
12) Start or stop new bladder training or diet therapy within 4 weeks befor registration
13) Patients who has received bladder instillation therapy, electrical stimulation therapy, or acupuncture and moxibustion within 12 weeks before registration
14) Patients with serious hepatic or kidney damage
15) Patients with serious heart disease
16) Patients with malignant tumors which effect their general status or survival time
17) Patients with the history of serious drug-induced adverse effect
18) Patients who are in pregnancy, while breast-feeding, or have possibilities of them, or desire pregnancy in test period
19) Patients who have taken part in the her clinical research within 12 weeks
20) Patients who have taken part in the her clinical research within 12 weeks
21) Patients who are inadequate, which their physicians assessed it

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Narifumi Matsumoto

Organization

Koushinka Hospital

Division name

South Osaka Urinary Center

Zip code

Address

Koushinkai Hospital, 40 Toyota, Minami-ku, Sakai-shi, Osaka

TEL

072-284-1182

Email

Name of contact person

1st name
Middle name
Last name	Comprehensive Support Project for Clinical Research Office

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for Clinical Research Office on ,Lifestyle-related disease

Zip code

Address

1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051

TEL

03-5287-2633

Homepage URL

Email

info@csp.or.jp

Institute

Koushinkai Hospital

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

07

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

06

Month

27

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

01

Day

Last follow-up date

2009

Year

03

Month

01

Day

Date of closure to data entry

2009

Year

11

Month

01

Day

Date trial data considered complete

2009

Year

11

Month

01

Day

Date analysis concluded

2010

Year

01

Month

01

Day

Other related information

Registered date

2008

Year

07

Month

16

Day

Last modified on

2010

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001527