Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Ficus deltoidea leaves, Cinnamomum cassia and Black seed powdered extract have long been used
      for the treatment of type 2 diabetes mellitus.
    

Detailed description: 
      Diabetes Mellitus (DM), commonly referred to as Diabetes is defined by World Health
      Organization (WHO) as a group of metabolic disorders characterized by chronic Hyperglycemia
      resulting from defects in insulin secretion, insulin action or both. Long-term organ damage,
      organ dysfunction and organ failure are associated with the chronic Hyperglycemia of
      Diabetes. Possible Diabetes complications can be classified into two major categories;
      macrovascular and microvascular including Ischemic Heart Disease (IHD), Peripheral Vascular
      Disease (PVD), and Cerebrovascular Disease (CVD) "macrovascular", and Nephropathy,
      Retinopathy, and Neuropathy "microvascular" resulting in organ and tissue damage in almost
      one third to one half of population with diabetes.

      According to the International Diabetes Federation (IDF), the three main types of Diabetes
      are Type 1 Diabetes, Type 2 Diabetes and Gestational Diabetes. Type 1 DM, formerly described
      as "Insulin Dependent Diabetes Mellitus" (IDDM) results from β-cells destruction, usually
      leading to absolute deficiency of insulin. Type 2 DM formerly described as
      "Non-Insulin-Dependent Diabetes Mellitus" (NIDDM) results from a progressive insulin
      secretory defect on the background of insulin resistance. Gestational Diabetes, which appears
      during pregnancy, is associated with increasing the risk of developing type 2 Diabetes in
      both mother and child later in life.

      Diabetes is a rapidly growing health concern in both developed and developing nations and its
      prevalence is continuously increasing worldwide. Globally, in 2014, approximately 422 million
      adults were having diabetes, with type 2 making up about 91%of the cases. In 2015, according
      to IDF, an estimated 415 million adults were having diabetes along with an estimated 318
      million adults with impaired glucose tolerance. Both WHO and IDF predict that by 2030, this
      number will be doubled. In 2016 the WHO global report on Diabetes stated that the prevalence
      of Diabetes has increased faster in low- and middle-income countries than in high-income
      countries.

      Type 2 Diabetes is characterized by insulin resistance and/or abnormal insulin secretion,
      either of which may predominate. It is associated with several metabolic defects such as
      obesity, hypertension, and dyslipidemia, which contribute to the very high rate of
      cardiovascular morbidity and mortality.

      Medicinal herbs were used to treat a wide range of diseases long time before the birth of
      conventional medicine systems. The World Health Organization (WHO) has listed 21,000 plant
      names, which are used for medicinal purposes around the world, so despite the fact that
      medicinal herbs are at times misconceived as being unscientific, their continual existence
      proves they are able to be alternatives or complementary to conventional drugs at some point.

      Specifically, Ficus deltoidea leaves, Cinnamomum cassia L. powdered Extract and Black seed
      powdered extract have been used for the treatment of Diabetes Mellitus and other medical
      conditions for over 2000 years. Ficus deltoidea is an evergreen shrub reaching to 2 meters of
      height, with whitish grey bark, broadly spoon-shaped to obovate leaves and spherical or round
      figs. Over the years, it has been used to treat many diseases such as; Diabetes Mellitus,
      Hypertension, Hyperlipidemia and Gout. Numerous studies were conducted over the past years to
      assess the safety of Ficus deltoidea, Cinnamomum cassia L. powdered extract and Black seed
      powdered extract and their efficacy in treating type 2 Diabetes Mellitus.

      As the available data on NW Low-Glu efficacy, safety and dosing regimen is not enough, this
      study will be conducted to compare the hypoglycemic effect of two doses of a herbal medicinal
      product of ficus and Cinnamomum cassia L. powdered Extract + Black seed powdered extract (NW
      Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients
      newly diagnosed with type II diabetes mellitus.
    

Intervention name(s): Natural Wellness Low-Glu low dose; Natural Wellness Low-Glu high dose; Metformin
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses; The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses; A total dose of 2000 mg was administered per day.
Other intervention name(s): Mas Cotek powdered Extract 300 mg + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a double-blind, double dummy, randomized, active-controlled, three-arm, parallel-group, interventional phase II clinical trial to investigate efficacy and safety of a herbal medicinal product of (NW Low-Glu) in patients newly diagnosed with type II diabetes mellitus.
Study duration: 3 months of recruitment and 3 months of treatment. Sample Size: It was planned to enroll 68 patients per arm, 204 in total. Participants were patients between 18 and 65 years of age, newly diagnosed with type II diabetes mellitus and consenting to participate in this study.
Eligible patients were randomized in a 1:1:1 allocation ratio, into one of the three treatment groups, to receive either Metformin or one of the two doses of NW Low-Glu.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ficus deltoidea; HbA1c; weight; metabolic syndrome; medicinal plants