Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06961019

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, India, 382481

Actively Recruiting

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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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