ITMCTR2200005780尚未招募4 期
Efficacy and safety of Xiang-Sha-Liu-Jun-Zi tang (XSLJZT) for treatment of Semaglutide-induced gastrointestinal side effects:a multicentre, randomized, open-label trial
Hospital of Chengdu University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 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)aged 18-70 years (both inclusive).
- •(2)Diagnosed with type 2 diabetes.
- •(3)Patients who have Gastrointestinal Adverse Reactions and Diagnosed with Spleen-deficiency syndrome during the run-in period.
- •(4)Body mass index (BMI) greater than or equal to 25.0 kg/sqm.
- •(5)HbA1c of 7.0-10.0% ( both inclusive).
- •(6)Participants who have been taking other hypoglycemic drugs, such as insulin, oral hypoglycemic drugsrequires stable treatment for at least 3 months before screening.
- •(7)Intend to use Semaglutide.
- •(8)Signed the informed consent form.
排除标准
- •(1)History of type 1 diabetes,Secondary diabetes,gestational diabetes,Female who is pregnant,breast-feeding.
- •(2)Have had acute complications of diabetes in the past 3 months,such as ketoacidosis,lactic acidosis,hyperosmolar coma and other critical illnesses.
- •(3)concomitant with other systemic diseases such as severe impaired renal function(estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m2), heart failure (New York Heart Association Class IV) or any acute coronary or cerebrovascular event within 90 days before randomization.
- •(4)Patients who are in a state of stress or severely infected.
- •(5)History of pancreatitis (acute or chronic).
- •(6)Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •(7)History of Diabetic gastrointestinal disease (for example Esophageal syndrome, diabetic gastroparesis,Diabetes mellitus with diarrhea or constipation).
- •(8)Have had obvious digestive symptoms in the past 1 month,such as: nausea, vomiting, bloating, diarrhea, constipation (including adverse drug reactions, caused by diseases).
- •(9)Have been or are being treated with a other glucagon-like peptide-1 receptor agonists or Dipeptidyl peptidase 4 (DPP-4) inhibitors in the past.
- •(10)Evaluation of the nodules according to TI-RADS,patients were found to be in the TI-RADS 3 categories and above.
- •(11)There was no gastrointestinal reaction ,or have gastrointestinal reactions but did not meet the Spleen-deficiency syndrome within 2 weeks.
研究者
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