Actively Recruiting
Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients
Led by NovoBliss Research Pvt Ltd · Updated on 2026-02-05
14
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
N
NovoBliss Research Pvt Ltd
Lead Sponsor
Z
Zywie Ventures Private Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female individuals aged 18 to 65 years at consent
- Diagnosed with Type 2 Diabetes Mellitus
- HbA1c values between 6.5% and 8.0 gm%
- Managing Type 2 Diabetes Mellitus with diet, herbal supplements, and exercise for at least 8 weeks prior to screening (Group 1)
- Managing Type 2 Diabetes Mellitus with 500 mg Metformin dose (Group 2)
- Have prescription or diabetes-related lab reports at screening
- Willing to come fasting for each study visit
- Willing to give written informed consent and attend regular follow-up
- Agree not to use other diabetes medications besides the study treatment during the study
- Have not participated in a similar clinical study in the last 3 months
- Willing to use the test treatment throughout the study period
You will not qualify if you...
- Diagnosed with diabetes types other than Type 2, such as Type 1 or specific types caused by pancreatic injury, Cushing's syndrome, acromegaly, LADA, MODY
- Any diabetes-related organ damage within 6 months prior to screening including retinopathy, nephropathy, ischemic heart disease, peripheral vascular disease, cerebrovascular disease
- Taking weight loss medications or supplements, or participated in a weight loss program within 4 weeks prior to screening
- Taking glucose-modifying medications other than 500 mg Metformin within 8 weeks prior to screening
- History of drug or alcohol use
- History of smoking, current smoking, or use of smokeless tobacco
- Abnormal laboratory results warranting exclusion per investigator
- Uncontrolled hypertension defined as systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- Hypersensitivity to any components of the study treatment
- Planned major lifestyle changes (diet, exercise, significant travel) during the study
- Participation in any other treatment study within 90 days prior to screening
- Pregnant, breastfeeding, or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India, 382481
Actively Recruiting
Research Team
M
Maheshvari N Patel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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