ITMCTR2026001749进行中（未招募）Unknown
Real-world Safety and Efficacy Study of Buzhong Yiqi Mixture in Patients with Spleen-Stomach Qi Deficiency Syndrome
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •TCM syndrome diagnosis criteria:
- •(1) Patients with TCM syndrome differentiation matching Spleen-Stomach Weakness Syndrome, Qi Deficiency Fever Syndrome, Middle Qi Sinking Syndrome, or other relevant TCM patterns. Typical associated symptoms include poor appetite, lassitude and fatigue, disinclination to speak due to shortness of breath, pale tongue, feeble pulse, or anal prolapse, uterine prolapse, chronic diarrhea and dysentery, metrorrhagia; or fever with spontaneous sweating, preference for hot drinks, shortness of breath and fatigue, pale tongue, large and feeble pulse.
- •Western medical diagnosis criteria:
- •(1) Digestive system diseases: Diarrhea-predominant irritable bowel syndrome, peptic ulcer, ulcerative colitis, chronic diarrhea, functional dyspepsia, etc.
- •(2) Respiratory system diseases: Stable stage of chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, chronic cough, pediatric upper airway cough syndrome, etc.
- •(3) Tumor-related disorders: Postoperative gastrointestinal function recovery, nausea and vomiting, poor appetite, cancer-related fatigue syndrome, etc.
- •(4) Gynecological diseases: Uterine prolapse, habitual abortion, threatened abortion, postpartum urinary retention, female stress urinary incontinence, dysfunctional uterine bleeding, etc.
- •Meet the western medical diagnostic criteria for diseases of corresponding clinical departments, or the TCM diagnostic and syndrome differentiation criteria.
- •Aged 18–80 years old, with no restriction on gender.
- •Patients who are willing to receive treatment under this study protocol, have good treatment compliance, and sign the informed consent form.
排除标准
- •Patients who fail to meet the TCM syndrome differentiation criteria or western medical diagnostic criteria.
- •Subjects with known hypersensitivity to the investigational drug.
- •Pregnant or lactating women.
- •Patients suffering from severe cardiovascular, respiratory, renal, hematological, endocrine, neurological or psychiatric disorders, which, in the investigator's judgment, may:
- •(1) Interfere with the accurate evaluation of the safety or efficacy of the investigational drug; OR
- •(2) Expose the subject to unacceptable risks; OR
- •(3) Impair the subject's ability to complete the scheduled study procedures.
- •Subjects with severe hepatic or renal dysfunction (ALT/AST > 3 times ULN, eGFR < 45 mL/min).
- •Patients who are unable to complete the required treatment course and observation period specified in the study for any reason.
- •Subjects with cognitive impairment who cannot cooperate to finish scale assessments.
- •Any other subjects deemed unsuitable for participation in this study by the investigator.
研究者
相似试验
招募中
1 期
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants with Advanced Solid Malignancies2024-511453-22-00Kumquat Biosciences Inc.112
招募中
不适用
An observational study on the safety and therapeutic effects of oral administration of Quercefit in subjects with aging symptomsAge-related decline in physical function and aging-associated symptomsjRCT103026001810
招募中
不适用
An observational study on the safety and therapeutic effects of oral administration of NMN to subjects complaining of aging symptomsAge-related symptoms (e.g., fatigue, decreased concentration, sleep disturbance)jRCT103026002010
招募中
不适用
An observational study on the safety and therapeutic effects of eye drops containing pilocarpine as an active ingredient in subjects with presbyopia (farsightedness)Presbyopia (farsightedness)jRCT103026001310
招募中
不适用
An observational study on the safety and therapeutic effects of oral administration of SPP in subjects with aging symptomsAge-related symptoms (e.g., fatigue, decreased concentration, sleep disturbance)jRCT103026002210