Type2 Diabetes MellitusNCT06961019
Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients
A study testing Sugar support effervescent Tablets in people with Type2 Diabetes Mellitus, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Sugar support effervescent Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 25 Aug 2025to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the detailed description
A total of 14 male and non-pregnant |non-lactating female (7 patients managing diabetes with 500 mg Metformin dose and 7 patients managing by only dietary/ herbal supplements and exercise) with the age of 18-65 years will be enrolled to complete 12 subjects (6 patients managing diabetes with 500 mg Metformin dose and 6 patients managing by only dietary/ herbal supplements and exercise) the study. A sufficient number of patients will be pre-screened based on HbA1c (6.5% to 8% gm) levels to ensure that enough subjects successfully qualify the screening. The potential subjects will be screened on the basis of the inclusion and exclusion criteria only after obtaining the written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. The subject will be asked to bring the past medications, or laboratory reports along with on the study visit day. The subjects will be instructed to visit the facility as per the below visits:
Visit 01 (Within 15 Days from Day 01): Screening, Baseline Evaluation Visit 02 (Day 01): Enrolment, Test Treatment Starts Visit 03 (Day 30 + 2 Days): Evaluation, Test Treatment phase Visit 04 (Day 60 + 2 Days): Evaluation, Test Treatment phase Visit 05 (Day 90 + 2 Days): Final Evaluations, End of the study
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Sugar support effervescent Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar support effervescent TabletsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sugar support effervescent Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C values
To evaluate the effectiveness of the test treatment in terms of change in HbA1C values
Measured: 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
Measured: 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
Measured: 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
To evaluate the effectiveness of the test treatment in terms of change in body weight
Measured: 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
To evaluate the effectiveness of the test treatment in terms of change in the waist to hip circumference
Measured: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Change in BMI
To evaluate the effectiveness of the test treatment in terms of change in BMI
Measured: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Change in Satiety score by VAS scoring scale
To evaluate the effectiveness of the test treatment in terms of change in satiety (10- High Satiety Level and 1- Low satiety level)
Measured: 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)
To evaluate the effectiveness of the test treatment in terms of change in Quality-of-life questionnaire
Measured: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start25 Aug 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, MBBS, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961019
- Sponsor's protocol ID
- NB250012-ZV
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06961019
- Acronym / sponsor ID
- NB250012-ZV
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 14 male and non-pregnant |non-lactating female (7 patients managing diabetes with 500 mg Metformin dose and 7 patients managing by only dietary/ herbal supplements and exercise) with the age of 18-65 years will be enrolled to complete 12 subjects (6 patients managing diabetes with 500 mg Metformin dose and 6 patients managing by only dietary/ herbal supplements and exercise) the study. A sufficient number of patients will be pre-screened based on HbA1c (6.5% to 8% gm) levels to ensure that enough subjects successfully qualify the screening. The potential subjects will be screened on the basis of the inclusion and exclusion criteria only after obtaining the written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. The subject will be asked to bring the past medications, or laboratory reports along with on the study visit day. The subjects will be instructed to visit the facility as per the below visits:
Visit 01 (Within 15 Days from Day 01): Screening, Baseline Evaluation Visit 02 (Day 01): Enrolment, Test Treatment Starts Visit 03 (Day 30 + 2 Days): Evaluation, Test Treatment phase Visit 04 (Day 60 + 2 Days): Evaluation, Test Treatment phase Visit 05 (Day 90 + 2 Days): Final Evaluations, End of the study
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm Sugar support effervescent Tablets | Experimental | Other: Sugar support effervescent TabletsT2DM 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 |
| Test Arm Placebo | Experimental | Other: Sugar support effervescent TabletsT2DM 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar support effervescent TabletsDissolve 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 | Test Arm Placebo, Test Arm Sugar support effervescent Tablets |
Primary outcome
Change in HbA1C values
Time frame: Before administration on Day 01 and post dose on Day 90
To evaluate the effectiveness of the test treatment in terms of change in HbA1C values
Change in FBG level
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
To evaluate the effectiveness of the test treatment in terms of change in FBG Level
Change in PPBG level
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
To evaluate the effectiveness of the test treatment in terms of change in PPBG level
5 secondary outcomes
Change in body weight using by using calibrated weighing balance
Time frame: 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
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Change in BMI
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Change in Satiety score by VAS scoring scale
Time frame: 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)
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel, MBBS principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar support effervescent Tablets in people with Type2 Diabetes Mellitus, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1C values (time frame: Before administration on Day 01 and post dose on Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.