Study of Fuling Yunhua Granules and Dihuang Baoyuan Granules for Treating Type 2 Diabetes in Patients with Poor Blood Sugar Control After Diet and Exercise

What this Trial Is About

Researchers are evaluating the effectiveness and safety of sequential therapy using two herbal granules, Fuling Yunhua Granules prescription A and Dihuang Baoyuan Granules prescription B, in adults with type 2 diabetes who have poor blood sugar control despite diet and exercise. This Phase 2 trial is designed as a multicenter, randomized, double-blind, placebo-controlled study to compare these treatments in patients who have not used diabetes drugs or have minimal prior drug use. The study aims to improve blood sugar control and measures changes in HbA1c as the main outcome. The study includes several periods a 2-week screening, a 1-week baseline during which continuous glucose monitoring CGM data is collected, a 12-week treatment phase, and a 1-week follow-up. Participants are randomly assigned to one of four groups receiving either the active granules in different sequences or placebos matching these granules. An interim analysis will be done after 30 participants complete 4 weeks of treatment to evaluate glucose control changes and guide study decisions. Participants will undergo regular assessments including blood tests for HbA1c, fasting plasma glucose, lipid profiles, and body weight. CGM data will be used to monitor glucose levels and variability. Safety and adherence will be closely observed throughout the treatment and follow-up periods. The total study duration per participant is approximately 16 weeks, including screening, treatment, and follow-up.

Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients