| 基本情報/Basic information |
| 一般向け試験名/Public title |
慢性C型肝炎および肝硬変患者におけるヘリコバクターピロリ菌除菌療法の有用性の検討 |
Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis |
| 一般向け試験名略称/Acronym |
慢性C型肝炎および肝硬変患者におけるH.pylori除菌療法の有用性の検討 |
Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis |
| 科学的試験名/Scientific Title |
慢性C型肝炎および肝硬変患者におけるヘリコバクターピロリ菌除菌療法の有用性の検討 |
Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis |
| 科学的試験名略称/Scientific Title:Acronym |
慢性C型肝炎および肝硬変患者におけるH.pylori除菌療法の有用性の検討 |
Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis |
| 試験実施地域/Region |
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| 目的/Objectives |
| 目的1/Narrative objectives1 |
慢性C型肝炎および肝硬変患者を対象に、H.pyloriのタイプ別での除菌治療後における血小板値の推移について検討し、今後の肝疾患患者におけるH.pylori除菌の必要性について検討する。 |
For chronic hepatitis C and a cirrhosis of the liver patient, I examine a change of the sanitization blood platelet value by the type distinction of H.pylori to be able to put after curing and examine necessity of the H.pylori sanitization in the future liver disease patient |
| 目的2/Basic objectives2 |
有効性/Efficacy |
| 目的2 -その他詳細/Basic objectives -Others |
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| 試験の性質1/Trial characteristics_1 |
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| 試験の性質2/Trial characteristics_2 |
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| 試験のフェーズ/Developmental phase |
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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
H.pylori除菌療法による血小板数の変化に影響を及ぼすH.pylori病原因子多型別の検討 |
Examination according to the H.pylori cause of the disease factor seasonal polymorphism to have an influence on a change of the number of the blood platelets by the H.pylori sanitization medical treatment |
| 副次アウトカム評価項目/Key secondary outcomes |
・除菌前血小板数値を低値群と高値群に分け、血小板数改善効果の検討
・インターフェロン投与患者における血小板数値の推移の検討
・H.pylori除菌療法による門脈圧亢進症胃症(PHG)、食道静脈瘤の改善効果
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I divide blood platelet numerical value before sanitization into the high price group with low value group, and it is examined the number of the blood platelets improvement effect.
The examination of the change of the blood platelet numerical value in the interferon dosage patient.
Portal vein pressure sthenia symptom stomach symptom (PHG),an improvement effect of the gullet varication by the H.pylori sanitization medical treatment.
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
血清抗体法でヘリコバクターピロリ菌を検査。
ヘリコバクターピロリ菌陽性患者に対してオメプラゾール20mg、アモキシシリン750mg、クラリスロマイシン400mg1日2回経口投与、1週間。
PPI休薬4週間後に尿素呼気試験で除菌判定。
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I inspect Helicobacter pylori by a serum antibody method.
It is omeprazole 20mg, amoxicillin 750mg, clarithromycin 400mg per day twice oral administration, one week for a Helicobacter pylori positive patient.
I do PPI rest medicine and I sanitize it by an urea breath test four weeks later and judge it.
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
①慢性C型肝炎および肝硬変の患者
②本研究の内容を理解し、文書により研究参加の同意が本人より得られる患者
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1.The patient of the chronic hepatitis C and cirrhosis of the liver
2.The patient that I understand the contents of this study, and an agreement of the study participation is provided from the person himself by a document
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| 除外基準/Key exclusion criteria |
①重度の肝障害のある患者（Child-pugh分類GradeC）
②その他、主治医が本研究の対象として不適当と判断した患者
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1.The patient with a severe liver damage(Child-pugh classification GradeC)
2.In addition, the patient who judged the chief physician to be inappropriate as an object of this study
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| 目標参加者数/Target sample size |
100 |
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