Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Suga
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.
| Condition(s) | Type2 Diabetes Mellitus |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | NovoBliss Research Pvt Ltd |
| Locations | Ahmedabad, Gujarat, India |
| Start date | 2025-08-25 |
| NCT ID | NCT06961019 |
| Official listing | https://clinicaltrials.gov/study/NCT06961019 |