YH1 in Poorly Controlled Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients
      worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many
      patients who take more than three kinds of oral hypoglycemic agents could not effectively
      control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are
      common side effect with insulin therapy, and many patients in Taiwan are not willing to
      receive insulin injection. It is common for diabetic patients treated with Chinese herbal
      medicine in China currently, and some therapeutic effects have been published in
      international journals. In this study, we will evaluate whether Chinese herbal medicine, YH1,
      enhances the glycemic control and is safe as add-on medication in poorly controlled type 2
      diabetes patients.

      A total of 46 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 7% from
      Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled in
      this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned to
      receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All
      subjects in both groups will also continuously receive their oral hypoglycemic agents without
      any dose or medicine change. During this 12-week period, the glycohemoglobin, fasting plasma
      glucose, 2h postprandial glucose, waist circumference, body weight, and body mass index will
      be assessed. In addition, insulin resistance, β -cell function, lipid profile, liver and
      renal function will also be evaluated. Independent statisticians will perform the data
      analysis at the end of the trial.
    

Detailed description: 
      The YH1 in one batch number was used, manufactured by Sun Ten Pharmaceutical Co., LTD., a
      renowned GMP manufacturer of concentrated herbal extract granules conforming to international
      standards. The YH1 was prepared in small granules, including concentrated herbal extract
      granules of Rhizoma Coptidis (50%) and SLBZS (50%). Both medicines have already been approved
      by the Ministry of Health and Welfare in Taiwan as ethical drugs. YH1 granules were packed in
      aluminum foil packages. The placebo was also prepared as granules by Sun Ten Pharmaceutical
      Co., LTD., and the packaging of the placebo was identical to that of YH1. The chemical
      composition of YH1 was analyzed and profiled by using a high performance liquid
      chromatography (HPLC) with photodiode array (PDA) detection. Fourteen components, allantoin,
      atractylenolide III, berberine, coptisine, ginsenoside Rb1, ginsenoside Re, ginsenoside Rg1,
      glycyrrhizin, liquiritin, pachymic acid, palmatine, platycodin D, magnoflorin and quercitrin,
      were simultaneously used in the qualitative analysis under the developed HPLC-PDA method. As
      for the quantitative detection, each gram of YH1 contained 20.05 mg berberine.
    

Intervention name(s): YH1 group; placebo group
Intervention type(s): Drug; Drug
Intervention description(s): Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.; Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.
Other intervention name(s): Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment