ITMCTR2200006100尚未招募1 期
Clinical Observation on Formula Granules of Huoxue-Jiangtang Decoction in Treating Prediabetes
Shenzhen Traditional Chinese Medicine Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(1) Meet the diagnosis of prediabetes, namely, the criteria of impaired fasting glucose and abnormal glucose tolerance in the classification of glucose metabolism state proposed by WHO in 1999. Which means that fasting glucose =6.1mmol/L, < 7.0mmol/L and/or OGTT 2-hour glucose =7.8mmol/L, < 11.1mmol/L.
- •(2) According to the clinical Research Guidelines of Traditional Chinese Medicine New Drugs and Guidelines for the Diagnosis and Treatment of Prediabetes Combined with Disease and Syndrome(2021-03-02).The diagnosis of deficiency of qi and Yin syndrome in prediabetes is as following: main symptoms: tiredness and fatigue, dry throat and dry mouth; Second symptoms: easy to hunger, thirst, shortness of breath and unwillingness to speak, feverish sensation over the five centers, palpitation and insomnia, dark urine and constipation. Subjects should meet at least 1 criteria of primary symptoms plus 2 criteria of secondary symptoms.
- •(3) =18 years old and < 70 years old.
- •(4) HBA1c =6.5%.
- •(5) Has not participated in any interventional clinical study or clinical trial in the past 3 months.
- •(6) Be able and willing to sign written informed consent and complete the study.
排除标准
- •(1) Patients with any type of diabetes whose diagnosis is clear.
- •(2) Women during pregnancy and lactation.
- •(3) Patients with chronic kidney disease (eGFR< 60mL/min/1.73m2 and/or serum creatinine >133µmol/L), severe liver dysfunction (any liver enzyme > 3 upper Limit Of Normal; abnormal coagulation function or bilirubin), severe cardiac dysfunction (such as NYHA ? or above heart failure, myocardial infarction, arrhythmia, etc), acute stage of cerebrovascular disease, or malignant diseases that are being treated or have not been fully alleviated or cured.
- •(4) Patients who used high-dose probiotics (daily intake > 108cFU) in the last 6 months.
- •(5) Patients who used glucocorticoids, cytokines that can stimulate the body's immune system, methotrexate and other immunosuppressants in the last 6 months.
- •(6) Patients who systematacially used antibiotics in the last 3 months.
- •(7) Patients who used local antibiotics in oral cavity within 7 days (such as toothpaste and mouthwash containing antibiotics, etc.).
- •(8) Patients who ate erratically in the past 3 months (the same meal time interval of more than 2 hours).
- •(9) Patients with untreated oral abscess.
- •(10) Patients with oral fungal infection.
- •(11) Patients with oral precancerous lesions or oral cancers.
- •(12) Patients with chronic periodontal diseases requiring long-term treatment.
- •(13) Patients who are allergic to any of the ingredients in linoleic solution.
- •(14) Persons who are not suitable for participating in this project according to the researcher because of mental, psychological factors, etc.
研究者
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