Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Purezen Health Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female participants aged 18 to 65 years at the time of enrollment. 2. Participants diagnosed with Type 2 Diabetes Mellitus, defined as: - HbA1c greater than or equal to 7.0 percentage to 8.5 percentage - Fasting Blood Sugar (FBS) between 130 170 mg/dL - Postprandial Blood Sugar (PPBS) between 180 230 mg/dL - Participants who are clinically stable and able to comply with study procedures and scheduled visits. 3. Participants willing to maintain a stable diet and lifestyle during the study period. 4. Participants who are willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants diagnosed with Type 1 Diabetes Mellitus. 2. Severe diabetes of HbA1c greater than 8.5 percentage 3. Severe FBS range of greater than 170 mg/dL 4. Severe PPBS range of greater than 230 mg/dL 5. Participants with severe diabetic complications or other serious diseases (e.g., advanced renal failure, hepatic failure, cancer, recent cardiovascular events). 6. Uncontrolled hypertension. 7. Known hypersensitivity or allergy to any component of the investigational product. 8. Use of other antidiabetic supplements during the study. 9. Participants currently using sulfonylureas or other antidiabetic medications associated with a high risk of hypoglycaemia. 10. Pregnant or lactating women, or women planning to become pregnant during the study period. 11. Participation in another clinical trial within 3 months prior to screening. 12. History of drug abuse, alcohol abuse, or substance abuse within the past 3 months. 13. Current alcohol dependence or clinically significant alcohol use. 14. Current heavy smoking or substance use that may interfere with study participation or outcomes as assessed by the Investigator. 15. Any clinically significant medical or psychiatric condition that, in the Investigator s opinion, may interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Glycated Hemoglobin (HbA1c) a) Definition: Evaluation of improvement in long-term glycemic control in participants receiving Sugar Stopper Capsule as an adjunct to standard antidiabetic therapy. b) Assessment Method: HbA1c (percentage) will be measured using standardized laboratory methods. c) Time Points: Baseline (Day 0) and Day 90 2 days. d) Endpoint Measure: Mean change from Baseline in HbA1c (percentage) to Day 90 2 days. Timepoint: Visit 0 - Day 0 Visit 1 - Day 30 2 days Visit 2 - Day 60 2 days Visit 3 - Day 90 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Quality of Life (WHOQOL-BREF) a) Definition: Evaluation of improvement in overall quality of life in participants with Type 2 Diabetes Mellitus receiving adjunct therapy. b) Assessment Method: WHOQOL-BREF questionnaire assessing four domains (Physical Health, Psychological, Social Relationships, Environment). c) Time Points: Baseline (Day 0) and Day 90 2 days. d) Endpoint Measure: 1) Mean change from Baseline in total WHOQOL-BREF score. 2) Mean change from Baseline in individual domain scores at Day 90 2 days. Timepoint: Visit 0 - Day 0 Visit 1 - Day 30 2 days Visit 2 - Day 60 2 days Visit 3 - Day 90 2 days;2. Change in Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) a) Definition: Evaluation of improvement in fasting and post-meal glycemic control with Sugar Stopper Capsule as an adjunct to ongoing antidiabetic therapy. b) Assessment Method: FBS (mg/dL) and PPBS (mg/dL) measured using standardized laboratory methods. c) Time Points: Baseline (Day 0), Day 30 2 days, Day 60 2 days, Day 90 2 days. d) Endpoint Measure: Mean change from Baseline in FBS (mg/dL) and PPBS (mg/dL) at each post-baseline visit. Timepoint: Visit 0 - Day 0 Visit 1 - Day 30 2 days Visit 2 - Day 60 2 days Visit 3 - Day 90 2 days;3. Safety and Tolerability - Definition: Evaluation of overall safety and tolerability of the investigational product when administered as an adjunct to standard antidiabetic treatment. - Assessment Method: - Monitoring and documentation of adverse events (AEs) and serious adverse events (SAEs), including severity and causality assessment - Assessment of vital signs (blood pressure, pulse rate, respiratory rate and temperature) - Physical examination findings evaluated by the Investigator at each visit. - Time Points: - AEs/SAEs: Continuous throughout the study duration (Day 0 to Day 90) - Vital signs: Baseline (Day 0), Day 30 2 days, Day 60 2 days, Day 90 2 days - Physical examina | — |
Countries
India
Contacts
Public ContactMamatha B Gokavi
Purezen Health Solutions Private Limited
Outcome results
None listed