Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients

NCT06961019 | Recruiting

• 1 other identifier: NB250012-ZV
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change in HbA1C values

  To evaluate the effectiveness of the test treatment in terms of change in HbA1C values

  Before administration on Day 01 and post dose on Day 90

• Change in FBG level

  To evaluate the effectiveness of the test treatment in terms of change in FBG Level

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

• Change in PPBG level

  To evaluate the effectiveness of the test treatment in terms of change in PPBG level

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

Secondary Outcomes (5)

• Change in body weight using by using calibrated weighing balance

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

• Change in waist to hip circumference by using calibrated measuring tape

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

• Change in BMI

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

• Change in Satiety score by VAS scoring scale

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

• Chane in quality of life by Short Form Health Survey (SF-36)

  Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90

Study Arms (2)

Test Arm Sugar support effervescent Tablets

EXPERIMENTAL

T2DM patients who are on treatment of 500mg Metformin dose. Test Product Name: Sugar support effervescent tablets Product By: Zywie Ventures Private Limited. Mode of Usage: Dissolve one effervescent tablet in a full glass of water (approximately 200 mL). Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation. Frequency: Twice a day before the meal Route of Administration: Oral

Other: Sugar support effervescent Tablets

Test Arm Placebo

EXPERIMENTAL

T2DM patients who are not on medication and Diabetes Mellitus managed by only dietary/herbal supplements and exercise . Test Product Name: Sugar support effervescent tablets Product By: Zywie Ventures Private Limited. Mode of Usage: Dissolve one effervescent tablet in a full glass of water (approximately 200 mL). Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation. Frequency: Twice a day before the meal Route of Administration: Oral

Other: Sugar support effervescent Tablets

Interventions

Sugar support effervescent Tablets OTHER

Dissolve one effervescent tablet in a full glass of water (approximately 200 mL). Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation. Frequency: Twice a day before the meal Route of Administration: Oral

Test Arm Placebo; Test Arm Sugar support effervescent Tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Male and female individuals with the age between 18 to 65 years at the time of consent.
• \) 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.
• \) 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.
• \) 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.
• \) Subjects who commit not to use other medications other than the allocated test treatment for the entire duration of the study.
• \) Subjects who have note participated in any other similar clinical study in last 3 months.
• \) Willing to use test treatment throughout the study period.

You may not qualify if:

• \) 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.
• \) Subjects taking any weight loss medication or dietary supplements, have participated in a weight loss program within 4 weeks prior to screening.
• \) 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.
• \) Subjects having history of drug or alcohol use. 6) Subjects having history of smoking or currently smoking or using any form of smokeless tobacco.
• \) 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.
• \) 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.
• \) Participation in a study of any other treatment within 90 days prior to the screening.
• \) Pregnant or breastfeeding or planning to become pregnant during the study period.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Zywie Ventures Private Ltd.: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, 382481, India

RECRUITING

Study Officials

• Nayan Patel, MBBS

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013286; maheshvari@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: August 25, 2025
• Primary Completion: March 14, 2026
• Study Completion: March 14, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)