Clinical observation of Xiang-Sha-Liu-Jun-Zi tang (XSLJZT) for gastrointestinal side effects induced by the novel GLP-1 analogue

Phase 4

• Conditions: Type 2 Diabetes mellitus

• Registration Number: ITMCTR2200005780
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom-Rating Scale ;the duration of individual gastrointestinal adverse events;

Secondary Outcome Measures

Name	Time	Method
HOMA2-IR;coefficient of variation;mean blood glucose;body weight;Fasting Plasma C-peptide;estimated HbA1c;fasting plasma glucose;Glucagon;time in range;mean amplitude of glycemic excursions;glycated serum protein;Hip circumference;The TCM symptom score system;Low density lipoprotein cholesterol;inter-quartile range;2-hour postprandial blood glucose;High density liptein cholesterol;waist circumference;HOMA2-%B;body mass index;Large amplitude of glycemic excursions;The standard deviation of blood glucose values;triglyceride;Waist-to-hip ratio;mean of daily differences;total cholesterol;