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

ConditionType2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovoBliss Research Pvt Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Male and female individuals with the age between 18 to 65 years at the time of consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugar support effervescent Tablets

    Other intervention

    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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Test Arm Sugar support effervescent TabletsExperimental treatment 1 intervention
Group B: Test Arm PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1C values

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

Time frame
Before administration on Day 01 and post dose on Day 90
2

Change in FBG level

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

Time frame
Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
3

Change in PPBG level

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

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

Secondary outcomes

1

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

Time frame
Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
2

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

Time frame
Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
3

Change in BMI

To evaluate the effectiveness of the test treatment in terms of change in BMI

Time frame
Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
4

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovoBliss Research Pvt Ltd

Lead sponsor

Zywie Ventures Private Ltd.

Collaborator

Source ClinicalTrials.gov
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