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临床试验/JPRN-UMIN000001253
JPRN-UMIN000001253已完成2 期

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

Koushinkai Hospital0 个研究点目标入组 30 人开始时间: 2008年7月16日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Koushinkai Hospital

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