Trial reportPloS one2019
The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Efficacy and safety of traditional Chinese classic prescriptions combined with metformin in the treatment of type 2 diabetes mellitus: a Bayesian network meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Evaluating efficacy and mechanism of traditional Chinese medicine in diabetes treatment: a meta-analysis and network pharmacology study.Frontiers in endocrinology · 2025Pooled it
- Evidence of traditional Chinese medicine for treating type 2 diabetes mellitus: from molecular mechanisms to clinical efficacy.Pharmaceutical biology · 2024Pooled it
- Immunomodulatory Role of Plants and Their Constituents on the Management of Metabolic Disorders: An Evidence-Based Review.Drug design, development and therapy · 2024Review
- The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.Frontiers in pharmacology · 2024Article
- Gut Microbiota and Bile Acids Mediate the Clinical Benefits of YH1 in Male Patients with Type 2 Diabetes Mellitus: A Pilot Observational Study.Pharmaceutics · 2022Article
- Shen-Ling-Bai-Zhu-San Enhances the Antipneumonia Effect of Cefixime in Children by Ameliorating Gut Microflora, Inflammation, and Immune Response.Evidence-based complementary and alternative medicine : eCAM · 2022Article
- Shenling Baizhu Powder Alleviates TNBS-Induced Colitis in Rats by Improving Intestinal Epithelial Permeability and Inhibiting Inflammation Through the TLR5/MyD88/NF-κB Pathway.Frontiers in pharmacology · 2022Article
- Article
- Herbal Medicines Targeting the ImprovedEvidence-based complementary and alternative medicine : eCAM · 2021Review
- The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Diabetes, metabolic syndrome and obesity : targets and therapy · 2021Article
- Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials.Frontiers in pharmacology · 2021Article
- Plant extracts as natural modulators of gut microbiota community structure and functionality.Heliyon · 2020Article
- Shen-ling-bai-zhu-san ameliorates inflammation and lung injury by increasing the gut microbiota in the murine model of Streptococcus pneumonia-induced pneumonia.BMC complementary medicine and therapies · 2020Article
- Assessment of the Pharmacological Properties and Phytochemical Profile ofBiomolecules · 2020Article
- The Effect of Chilgoza Pine Nut (Diabetes, metabolic syndrome and obesity : targets and therapy · 2020Article
- Medicinal Plants as a Potential and Successful Treatment Option in the Context of Atherosclerosis.Frontiers in pharmacology · 2020Review
- Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice.Pilot and feasibility studies · 2020Article
- Effective Dose ofFrontiers in pharmacology · 2020Article
- Prevention of Nonalcoholic Hepatic Steatosis by Shenling Baizhu Powder: Involvement of Adiponectin-Induced Inhibition of Hepatic SREBP-1c.Oxidative medicine and cellular longevity · 2020Article
Corrections and comments
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Authors and funding
15 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes.
methodsForty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation.
resultsAt week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial.
conclusionsThis pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.
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