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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
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
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India
RECRUITINGChange 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
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
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
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
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
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
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)
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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)
To evaluate the effectiveness of the test treatment in terms of change in Quality-of-life questionnaire
Time frame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90