Herbal effervescent tablets to help control blood sugar in people with type 2 diabetes
A Proof-of-Science, Single-Treatment, Two-Group, Clinical Evaluation of Safety, In-Use Tolerability, Efficacy of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus (T2DM) Patients
This will test whether a daily herbal effervescent tablet taken for 90 days helps adults with type 2 diabetes and HbA1c between 6.5% and 8.0%, including those managed by diet/herbs/exercise or on 500 mg metformin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | NovoBliss Research Pvt Ltd Academic / other |
| Locations | 1 site (Ahmedabad, Gujarat) |
| Trial ID | NCT06961019 on ClinicalTrials.gov |
What this trial studies
This is a small, prospective, single-treatment, two-group exploratory trial testing safety, tolerability, and preliminary efficacy of an herbal-based effervescent tablet over 90 days. Up to 14 participants (to yield 12 completers) aged 18–65 with HbA1c 6.5%–8.0% will be enrolled, split into two groups: one managed by diet/herbal supplements/exercise and one taking 500 mg metformin. Participants will start the test treatment at enrollment (Day 1) and return for visits at approximately Day 30, Day 60, and Day 90 for safety and outcome evaluations. The primary focus is on tolerability and safety, with secondary measures of blood glucose control and related labs.
Who should consider this trial
Good fit: Adults 18–65 with diagnosed type 2 diabetes and HbA1c between 6.5% and 8.0% who are either managing diabetes with diet/herbal supplements/exercise or taking a 500 mg metformin dose are ideal candidates.
Not a fit: People with HbA1c outside the 6.5%–8.0% range, taking other glucose-lowering medications, who are pregnant or lactating, or who have complicated or unstable diabetes are unlikely to benefit from this small exploratory trial.
Why it matters
Potential benefit: If successful, the tablets could offer a well-tolerated herbal option to help stabilize or modestly improve blood sugar in people with mildly elevated HbA1c.
How similar studies have performed: Similar herbal supplement approaches have limited and mixed high-quality evidence, so this specific effervescent formulation remains largely untested in rigorous clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ahmedabad, Gujarat
- NovoBliss Research Pvt Ltd — Ahmedabad, Gujarat, India (Recruiting)
Study contacts
- Principal investigator: Nayan Patel, MBBS — NovoBliss Research Private Limited
- Study coordinator: Maheshvari N Patel
- Email: maheshvari@novobliss.in
- Phone: 09909013286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.