Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Suppo… (NCT06961019) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients
India14 participantsStarted 2025-08-25
Plain-language 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
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1C values
Timeframe: Before administration on Day 01 and post dose on Day 90
2
Change in FBG level
Timeframe: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
3
Change in PPBG level
Timeframe: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90