RecruitingPhase 2NCT06575478

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

Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Type 2 Diabetes Patients With Poor Blood Glucose Control After Diet and Exercise Intervention: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study


Sponsor

Beijing Supreme Life Pharmaceutical Technology Co., Ltd.

Enrollment

72 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two traditional Chinese herbal medicines — Fuling Yunhua Granules and Dihuang Baoyuan Granules — in people who have recently been diagnosed with type 2 diabetes and have not yet started medication. **You may be eligible if...** - You are between 18 and 75 years old - You were diagnosed with type 2 diabetes at least 8 weeks ago - You have been managing your blood sugar with diet and exercise for the past 3 months (no diabetes medications) - Your HbA1c (3-month blood sugar average) is between 7.5% and 11% - Your fasting blood sugar is between 7.0 and 13.9 mmol/L **You may NOT be eligible if...** - You are currently taking any diabetes medication - You have serious kidney, liver, or heart disease - You are pregnant or breastfeeding - You have a history of severe low blood sugar episodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFuling Yunhua Granules

Fuling Yunhua Granules

DRUGFuling Yunhua Granules matched placebo

Fuling Yunhua Granules placebo

DRUGDihuang Baoyuan Granules

Dihuang Baoyuan Granules

DRUGDihuang Baoyuan Granules matched placebo

Dihuang Baoyuan Granules placebo


Locations(1)

Peking University People's Hospital

Beijing, China

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NCT06575478


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