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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名: | UMIN ID: |
試験進捗状況 | 試験終了/Completed |
UMIN試験ID | UMIN000003954 |
受付番号 | R000004763 |
科学的試験名 | 機能性ディスペプシアに対する六君子湯の有効性・安全性の科学的エビデンスを創出するための二重盲検無作為化プラセボ対照比較試験 |
一般公開日(本登録希望日) | 2010/07/27 |
最終更新日 | 2014/05/09 |
基本情報/Basic information | |||
一般向け試験名/Public title | 機能性ディスペプシアに対する六君子湯の有効性・安全性の科学的エビデンスを創出するための二重盲検無作為化プラセボ対照比較試験 | Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia | |
一般向け試験名略称/Acronym | 機能性ディスペプシアに対する六君子湯の有効性・安全性の科学的エビデンスを創出するための二重盲検無作為化プラセボ対照比較試験 | Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia | |
科学的試験名/Scientific Title | 機能性ディスペプシアに対する六君子湯の有効性・安全性の科学的エビデンスを創出するための二重盲検無作為化プラセボ対照比較試験 | Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia | |
科学的試験名略称/Scientific Title:Acronym | 機能性ディスペプシアに対する六君子湯の有効性・安全性の科学的エビデンスを創出するための二重盲検無作為化プラセボ対照比較試験 | Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia | |
試験実施地域/Region |
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対象疾患/Condition | |||||
対象疾患名/Condition | 機能性ディスペプシア | Functional Dyspepsia | |||
疾患区分1/Classification by specialty |
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疾患区分2/Classification by malignancy | 悪性腫瘍以外/Others | ||||
ゲノム情報の取扱い/Genomic information | いいえ/NO |
目的/Objectives | ||
目的1/Narrative objectives1 | 六君子湯のFDに対する有効性と安全性について、プラセボを対照として比較検討する。 | To examine the efficacy and safety of Rikkunshito in Functional Dyspepsia by double-blind, randomized, placebo-controlled trial |
目的2/Basic objectives2 | 安全性・有効性/Safety,Efficacy | |
目的2 -その他詳細/Basic objectives -Others | ||
試験の性質1/Trial characteristics_1 | 検証的/Confirmatory | |
試験の性質2/Trial characteristics_2 | 実務的/Pragmatic | |
試験のフェーズ/Developmental phase | 該当せず/Not applicable |
評価/Assessment | ||
主要アウトカム評価項目/Primary outcomes | GPAスコアによる投与8週後の改善率 | Improvement rate of global patient assessment at 8 weeks after initial treatment |
副次アウトカム評価項目/Key secondary outcomes | 1.GSRSスコアの投与前後の変化率
2.ディスペプシア症状の改善率 |
1.Rate of Gastrointestinal Symptom Rating Scale(GSRS) after treatment
2.Improvement rate of dyspeptic symptoms by symptomatic scale |
基本事項/Base | ||
試験の種類/Study type | 介入/Interventional |
試験デザイン/Study design | ||
基本デザイン/Basic design | 並行群間比較/Parallel | |
ランダム化/Randomization | ランダム化/Randomized | |
ランダム化の単位/Randomization unit | 個別/Individual | |
ブラインド化/Blinding | 二重盲検/Double blind -all involved are blinded | |
コントロール/Control | プラセボ・シャム対照/Placebo | |
層別化/Stratification | いいえ/NO | |
動的割付/Dynamic allocation | いいえ/NO | |
試験実施施設の考慮/Institution consideration | 施設を考慮していない/Institution is not considered as adjustment factor. | |
ブロック化/Blocking | はい/YES | |
割付コードを知る方法/Concealment | 中央登録/Central registration |
介入/Intervention | |||
群数/No. of arms | 2 | ||
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 | 漢方薬 | traditional Chinese medicine | |
介入2/Interventions/Control_2 | プラセボ | placebo | |
介入3/Interventions/Control_3 | |||
介入4/Interventions/Control_4 | |||
介入5/Interventions/Control_5 | |||
介入6/Interventions/Control_6 | |||
介入7/Interventions/Control_7 | |||
介入8/Interventions/Control_8 | |||
介入9/Interventions/Control_9 | |||
介入10/Interventions/Control_10 |
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.RomeⅢを満たす機能性ディスペプシア
2.登録前の2週間に計4日以上、ディスペプシア症状のスケールで3段階以上の症状があった患者 3.登録前のGSRSの「腹痛ドメイン」「消化不良ドメイン」が4点以上である患者。もしくは「腹痛ドメイン」「消化不良ドメイン」を構成する項目の1つ以上が5点以上の患者 4.年齢20歳以上 5.性別:不問 6.入院・外来:不問 7.文書による同意が得られた方 |
1. Patients with functional dyspepsia diagnosed according to the Rome three classification
2. Patients with dyspeptic symptom by symptomatic scale 3 points or more, for over four days, for two weeks before registration 3.Patients have average 4 points or more by abdominal pain domain or dyspepsia domain of GSRS, or patients have 5 points or more, at one more items of abdominal pain domain or dyspepsia domain of GSRS 4.Patients aged 20 or older 5.regardless of sex 6.regardless of admission to hospital 7.Patients whose written informed consent has been obtained |
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除外基準/Key exclusion criteria | 1.器質的疾患が認められる患者
2.上部消化管手術の既往がある患者 3.胃切除の既往がある患者 4.症状の原因が明らかな患者 5.NSAIDsまたは低用量アスピリンを3ヶ月服用した際にディスペプシア症状が生じた患者 6.脳に器質的障害の既往を有する患者、統合失調症またはうつ病と診断された患者 7.アルコール依存または薬物依存のある患者 8.甲状腺機能亢進症などの重篤なホルモン異常を有する患者 9.重篤な心・肝・腎機能障害、感染症または造血器障害を有する患者 10.本研究で指標する試験薬剤の成分に対し過敏症の既往歴を有する患者 11.妊婦、授乳婦または妊娠している可能性のある患者、試験期間に妊娠を希望する患者 12.過去6ヶ月以内にH.pylori除菌治療を受けた患者 13.同意取得前1週間以内に、酸分泌抑制薬、消化管機能賦活薬、制酸薬、抗コリン薬、コリン作動薬、精神安定剤、抗不安薬、抗うつ薬を服用した患者 14.過敏性腸症候群(irritable Bowel Syndrome:IBS)の疑いがある患者 15.その他、担当医師が不適当とした患者 |
1. Patient with Organic disease such as reflux esophagitis (> grade A) and erosive gastritis.
2. Patients with past history of upper gastrointestinal surgery 3. Patients with past history of gastrectomy 4.Patients with an obvious cause of symptom 5. NSAIDs or low-dose aspirin -related dyspepsia 6. Patients with organic disease in the brain or with psychological disorders 7. Patients with alcoholics or with drug dependence 8. Severe endocrine disease including hyperthyroidism 9. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 10. Drug allegy for Rikkunshito 11.Expectant mother, mother with breast-feeding, or females who wish to become pregnant 12.Patient with H.pylori eradication within 6 months 13.Patients who take gastric secretion inhibitor, prokinetic agent, gastric antacid, anticholineric drug, cholinergic agent, tranquilizer, anxiolytic agent drug, antidepressive drug within 1 week 14. Patients with suspected IBS 15. other not applicable person recognized by a doctor |
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目標参加者数/Target sample size | 430 |
責任研究者/Research contact person | ||||||||||||||
責任研究者/Name of lead principal investigator |
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所属組織/Organization | 慶應義塾大学医学部 | Keio University School of Medicine | ||||||||||||
所属部署/Division name | 内科学(消化器) | Division of Gastroenterology and Hepatology, Department of Internal Medicine | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 160-8582東京都新宿区信濃町35 | 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan | ||||||||||||
電話/TEL | ||||||||||||||
Email/Email |
試験問い合わせ窓口/Public contact | ||||||||||||||
試験問い合わせ窓口担当者/Name of contact person |
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組織名/Organization | 慶應義塾大学医学部 | Keio University School of Medicine | ||||||||||||
部署名/Division name | クリニカルリサーチセンター | Center for Clinical Research | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 160-8582東京都新宿区信濃町35 | 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan | ||||||||||||
電話/TEL | 03-5363-3288 | |||||||||||||
試験のホームページURL/Homepage URL | ||||||||||||||
Email/Email |
実施責任組織/Sponsor | ||
機関名/Institute | その他 | Office of Rikkunshito study |
機関名/Institute (機関選択不可の場合) |
六君子湯研究事務局 | |
部署名/Department |
研究費提供組織/Funding Source | ||
機関名/Organization | その他 | Minister of Health, Labour and Welfare |
機関名/Organization (機関選択不可の場合) |
厚生労働省 | |
組織名/Division | ||
組織の区分/Category of Funding Organization | ||
研究費拠出国/Nationality of Funding Organization | 日本 | Japan |
その他の関連組織/Other related organizations | ||
共同実施組織/Co-sponsor | ||
その他の研究費提供組織/Name of secondary funder(s) |
IRB等連絡先(公開)/IRB Contact (For public release) | ||
組織名/Organization | ||
住所/Address | ||
電話/Tel | ||
Email/Email |
他機関から発行された試験ID/Secondary IDs | ||
他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
試験ID1/Study ID_1 | ||
ID発行機関1/Org. issuing International ID_1 | ||
試験ID2/Study ID_2 | ||
ID発行機関2/Org. issuing International ID_2 | ||
治験届/IND to MHLW |
試験実施施設/Institutions | ||
試験実施施設名称/Institutions |
その他の管理情報/Other administrative information | ||||||||
一般公開日(本登録希望日)/Date of disclosure of the study information |
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関連情報/Related information | ||
プロトコル掲載URL/URL releasing protocol | ||
試験結果の公開状況/Publication of results | 最終結果が公表されている/Published |
結果/Result | ||
結果掲載URL/URL related to results and publications | http://onlinelibrary.wiley.com/doi/10.1111/nmo.12348/full | |
組み入れ参加者数/Number of participants that the trial has enrolled | ||
主な結果/Results | Neurogastroenterol Motil. 2014 Apr 28. doi:10.1111/nmo.12348. [Epub ahead of print] PubMed PMID: 24766295.
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BACKGROUND:
Rikkunshito, a standardized Japanese herbal medicine, is thought to accelerate gastric emptying and relieve dyspepsia, although no large-scale, randomized, placebo-controlled trials of rikkunshito have been conducted. This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia (FD). METHODS: FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8 weeks after starting test drug, determined by global patient assessment (GPA). The improvement in four major dyspepsia symptoms severity scale was also evaluated. In addition, plasma ghrelin levels were investigated before and after treatment. KEY RESULTS: Two hundred forty-seven patients were randomly assigned. In the eighth week, the rikkunshito group had more GPA responders (33.6%) than the placebo (23.8%), although this did not reach statistical significance (p = 0.09). Epigastric pain was significantly improved (p = 0.04) and postprandial fullness tended to improve (p = 0.06) in the rikkunshito group at week 8. Rikkunshito was relatively more effective among Helicobacter pylori-infected participants (rikkunshito: 40.0% vs placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori-uninfected participants (rikkunshito: 29.3% vs placebo: 25.6%, p = 0.72). Among H. pylori-positive individuals, acyl ghrelin levels were improved just in rikkunshito group. There were no severe adverse events in both groups. CONCLUSIONS & INFERENCES: Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954). |
主な結果入力日/Results date posted | ||
結果掲載遅延/Results Delayed | ||
結果遅延理由/Results Delay Reason | ||
最初の試験結果の出版日/Date of the first journal publication of results | ||
参加者背景/Baseline Characteristics | ||
参加者の流れ/Participant flow | ||
有害事象/Adverse events | ||
評価項目/Outcome measures | ||
個別症例データ共有計画/Plan to share IPD | ||
個別症例データ共有計画の詳細/IPD sharing Plan description |
試験進捗状況/Progress | ||||||||
試験進捗状況/Recruitment status | 試験終了/Completed | |||||||
プロトコル確定日/Date of protocol fixation |
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倫理委員会による承認日/Date of IRB | ||||||||
登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date |
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入力終了(予定)日/Date of closure to data entry |
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データ固定(予定)日/Date trial data considered complete |
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解析終了(予定)日/Date analysis concluded |
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その他/Other | ||
その他関連情報/Other related information |
管理情報/Management information | ||||||||
登録日時/Registered date |
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最終更新日/Last modified on |
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閲覧ページへのリンク/Link to view the page | |
URL(日本語) | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000004763 |
URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004763 |
研究計画書 | |
登録日時 | ファイル名 |
研究症例データ仕様書 | |
登録日時 | ファイル名 |
研究症例データ | |
登録日時 | ファイル名 |