研究疾病:
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功能性消化不良
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研究疾病代码:
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Target disease:
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Functional dyspepsia
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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非随机对照试验
Non randomized control
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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从自主神经系统平衡性、主要脑肠肽的前后变化,观察岭南火针对脑肠轴的作用,结合今后动物实验结果,探讨岭南火针对功能性消化不良肝郁脾虚证脑肠轴的作用机制。同时,观察岭南火针干预功能性消化不良(FD)肝郁脾虚证的临床效果和生存质量状态改善情况,证实岭南火针对FD肝郁脾虚证的疗效,从而指导岭南火针在功能性胃肠病的应用,为今后火针在胃癌防治中应用提供基础。
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Objectives of Study:
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From the changes of autonomic nervous system balance and the main brain gut peptides, the effect of Lingnan fire needling on brain gut axis was observed. Combined with the results of future animal experiments, we hope to study the mechanism of Lingnan fire needling on brain gut axis of liver depression and spleen deficiency syndrome of functional dyspepsia. At the same time, by observing the clinical effect of Lingnan fire needling on liver depression and spleen deficiency syndrome of functional dyspepsia (FD) and the improvement of quality of life, this study may confirm the curative effect of Lingnan fire needling on FD liver depression and spleen deficiency syndrome, so as to guide the application of Lingnan fire needling on functional gastrointestinal diseases and provide a basis for the application of fire needling on the prevention and treatment of gastric cancer in the future.
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药物成份或治疗方案详述:
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本项目采取非盲、非随机模式,根据患者各自意愿选择火针干预方案或者莫沙必利干预方案,分别纳入试验组和对照组,每组约65例。
1.试验组:采用火针干预方案。
选穴:中脘、足三里、内关、脾俞、胃俞、肝俞、太冲、阳陵泉
操作方法:
先针刺中脘、足三里、内关、脾俞、胃俞、阳陵泉和太冲。针刺完毕后,火针中脘、足三里、脾俞、肝俞、太冲。每4天治疗1次,连续治疗4周。
2.对照组:莫沙必利干预方案
口服莫沙必利片,每次5mg,一天三次,饭前服用,连续服用4周。
3.两组都辅助给予起居、生活、饮食健康指导。
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Description for medicine or protocol of treatment in detail:
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This project is a non blind and non randomized study. According to the wishes of the patients, fire acupuncture intervention or mosapride intervention were selected and entered into the experimental group or the control group, with about 65 cases in each group.
1. Experimental group: fire needle intervention scheme was adopted.
Selected acupoints: Zhongwan, Zusanli, Neiguan, Pishu, Weishu, Ganshu, Taichong, Yanglingquan
Operation:
First acupuncture Zhongwan, Zusanli, Neiguan, Pishu, Weishu, Yanglingquan and Taichong. After acupuncture, fire needling was applied to Zhongwan, Zusanli, Pishu, Ganshu and Taichong. Once every 4 days for 4 weeks.
2. Control group: mosapride intervention scheme was adopted.
Oral mosapride tablets, 5mg each time, three times a day, before meals for 4 weeks.
3. Both groups were assisted with daily life and diet health guidance.
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纳入标准:
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1)年龄介于18-65周岁;
2)符合功能性消化不良的诊断标准;
3)符合中医肝郁脾虚证;
4)患者功能性消化不良症状频率、症状严重程度II级以上;
5)患者自愿参与本研究,并签署书面知情同意书,愿意配合随访。
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Inclusion criteria
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1) Age between 18-65 years old;
2) Accord with the diagnostic criteria of functional dyspepsia;
3) Accord with the syndrome of liver depression and spleen deficiency in traditional Chinese medicine;
4) The frequency and severity of symptoms of functional dyspepsia were above grade II;
5) Patients volunteered to participate in the study, signed informed consent and were willing to cooperate with the study.
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排除标准:
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1)筛选前2周内接受过功能性消化不良药物或针灸治疗的患者;
2)筛选检查前2周内接受过任何手术的患者;
3)合并有糖尿病、凝血功能障碍或严重皮肤疾病的患者;
4)筛选检查时患者丙氨酸氨基转移酶(ALT)或天门冬氨酸氨基转移酶(AST)大于或等于本中心规定正常值上限的1.5倍,或内生肌酐清除率(CCr)大于本中心规定的正常值上限;
5)筛选检查时患者血常规白细胞总数(WBC)大于10.0X109/L或小于1.0X109/L;
6)患者有免疫缺陷疾病史(如HIV等),或癌症、恶性肿瘤病史,或自身免疫性疾病史,或心、脑血管严重疾病,或患有其他可能显著减少预期寿命疾病;
7)具有任何可能影响方案依从性的疾病史(如严重精神障碍、认知功能障碍、药物滥用或成瘾等);
8)妊娠或哺乳期妇女,或有生育能力且不愿/无法采取有效避孕措施者;
9)已知对本研究用药所含成分过敏者;
10)筛选检查前6个月内曾参加过任何药物临床试验者;
11)研究者判断不宜参加本研究的患者。
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Exclusion criteria:
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1) Patients who had received functional dyspepsia drugs or acupuncture treatment within 2 weeks before screening;
2) Patients who underwent any surgery within 2 weeks before screening;
3) Patients with diabetes, coagulation disorders or severe skin diseases
4) During screening examination, the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of the patient is greater than or equal to 1.5 times of the upper limit of normal value specified by the center, or the endogenous creatinine clearance (CCR) is greater than the upper limit of normal value specified by the center;
5) During screening examination, the total white blood cell count (WBC) of patients is greater than 10.0x109/l or less than 1.0x109/l;
6) The patient has a history of immune deficiency diseases (such as HIV), or a history of cancer, malignant tumor, or autoimmune diseases, or serious cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy;
7) Have any history of diseases that may affect program compliance (such as severe mental disorders, cognitive impairment, drug abuse or addiction);
8) Pregnant or lactating women, or those who are unwilling / unable to take effective contraceptives;
9) Those who are known to be allergic to the ingredients contained in the drug used in this study;
10) Those who have participated in any drug clinical trial within 6 months before screening examination;
11) The investigator judged that patients should not participate in this study
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研究实施时间:
Study execute time:
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从From
2021-11-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2021-12-12
至To
2022-06-30
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