Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients

Summary

This is a Proof-of-Science, exploratory, prospective, single-treatment, two-group, clinical safety, efficacy and tolerability study of herbal based Sugar support effervescent tablets on the patients with Type 2 Diabetes Mellitus.

Eligibility

Inclusion Criteria:

* 1\) Male and female individuals with the age between 18 to 65 years at the time of consent.

  2\) Subject diagnosed with T2DM. 3) Subjects with currently having HbA1c values between 6.5% to 8.0 gm%. 4) Subjects currently managing T2DM by dietary or herbal supplements and exercise only for at least 8 weeks prior to screening for Group 1.

  5\) Subjects currently managing T2DM by 500 mg Metformin dose for Group 2. 6) Subjects having prescription or diabetes related laboratory reports at the time of screening.

  7\) Subjects willing to come in fasting state for every study visit. 8) Subjects are willing to give written informed consent and are willing to come for regular follow up.

  9\) Subjects who commit not to use other medications other than the allocated test treatment for the entire duration of the study.

  10\) Subjects who have note participated in any other similar clinical study in last 3 months.

  11\) Willing to use test treatment throughout the study period.

Exclusion Criteria:

* 1\) Subjects diagnosed with other types of Diabetes like T1DM or specific type of DM (i.e., pancreatic injury induced DM, diabetes mellitus caused by Cushing's syndrome or acromegaly, Latent Autoimmune Diabetes in Adults (LADA), Maturing Onset diabetes of the young (MODY) etc.) 2) Subjects with any end organ damage due to diabetes (including microvascular complications like retinopathy, nephropathy and macrovascular complications like ischemic heart disease, peripheral vascular disease and cerebrovascular disease resulting in organ and tissue damage) within 6 months prior to screening.

  3\) Subjects taking any weight loss medication or dietary supplements, have participated in a weight loss program within 4 weeks prior to screening.

  4\) Subjects taking any glucose modifying medication like Sulfonylureas, Biguanides (Except 500 mg Metformin), Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 agonist, SGLT2 inhibitor, Alpha-glycosidase inhibitors or any other within 8 weeks prior to screening.

  5\) Subjects having history of drug or alcohol use. 6) Subjects having history of smoking or currently smoking or using any form of smokeless tobacco.

  7\) Subjects who have deviations in the laboratory reports which could warrant exclusion from the study, as per investigator's opinion.

  8\) Individuals with uncontrolled hypertension defined as Systolic blood pressure ≥ 140 mm Hg and/or Diastolic blood pressure ≥ 90 mm Hg with or without anti-hypertensives.

  9\) Subjects who are hypersensitive to any of the components of the treatment. 10) Subjects who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.

  11\) Participation in a study of any other treatment within 90 days prior to the screening.

  12\) Pregnant or breastfeeding or planning to become pregnant during the study period.

Conditions2

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