Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Zywie Ventures Private Ltd.
First posted: 2025-05-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

  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.

Primary outcomes:
measure: Change in HbA1C values
timeFrame: Before administration on Day 01 and post dose on Day 90
measure: Change in FBG level
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
measure: Change in PPBG level
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Secondary outcomes:
measure: Change in body weight using by using calibrated weighing balance
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
measure: Change in waist to hip circumference by using calibrated measuring tape
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
measure: Change in BMI
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
measure: Change in Satiety score by VAS scoring scale
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
measure: Chane in quality of life by Short Form Health Survey (SF-36)
timeFrame: Before administration on Day 01 and post dose on Day 30, Day 60 and Day 90
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Private Limited
name: Nayan Patel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: