Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(BCS) With Digestive Tract .
The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials
調査の概要
詳細な説明
Factors for the purpose of this study by observing theShenqifuzheng injection before and after treatment in patients with carcinoma due to fatigue scale scores, the classification of syndromes, the quality of life score changes and related laboratory index, evaluation factors ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with cancer-related fatigue and quality of life improved efficacy and safety. The experimental group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500 ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time daily, 14 days for continuous use, 7 days of rest, and 1 treatment for each 21 days, and 2 courses were observed. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment.
Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating - adopting the Piper fatigue scale revised Chinese version, compare the experimental group and the control group before and after treatment cancer-related fatigue rating difference have differences. Secondary efficacy evaluation index to compare the ECOG score difference before and after the treatment, the quality of life score difference before and after the treatment, TCM syndrome curative effect, single symptom curative effect of immune function, tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes the observation of vital signs, blood routine, urinary routine, routine stool, liver function, renal function, electrocardiogram examination, and adverse reactions during the treatment.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国
- 募集
- First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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コンタクト：
- lin lizhu, Dr.
- 電話番号：13501505588
- メール：13501505588@163.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 1. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology;
- 2. Diagnostic criteria for cancer-related fatigue;
- 3. Syndrome differentiation of Chinese medicine is a syndrome of lung temper;
- 4. Estimated survival over 3 months;
- 5. ECOG score is less than or equal to 3
- 6. Age 18 ~ 80 years old；
- 7. Non-surgical indications or reluctance to operate the surgical treatment;
- 8. 70 g/L or higher HGB;
- 9. Stop and chemotherapy for more than 1 month;
- 10. The patient is willing to accept the treatment of the programme, and can follow the doctor's advice to take the medicine and comply with the patient.
Exclusion Criteria:
1. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection:
- clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
- serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03)
- uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
- severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 5 times ULN; Bilirubin is greater than 1.5 times ULN.
- other diseases that need to be controlled: pulmonary congestion, etc.
- 2. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
- 3. Compliance.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：shenqifuzheng
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500ml shenqifuzheng daily（at day 1-14 and day22-36）through intravenous infusion.
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プラセボコンパレーター：0.9%sodium chloride
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500ml sodium chloride（0.9%）daily（at
day 1-14 and day22-36）through intravenous infusion.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Piper Fatigue Scale（PFS）
時間枠：42 days
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Change From Baseline in Piper Fatigue Scores at 42 days
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42 days
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協力者と研究者
捜査官
- 主任研究者：lin lizhu, Dr.、First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- livzon-sqfz-BCS
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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shenqifuzheng injectionの臨床試験
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