Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
None listed
Sponsors
Sahyadri Ayurvedic Life Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be eligible to participate if they meet all of the following criteria: 1. Adults of either gender, aged 18 to 75 years at the time of enrollment. 2. Participants diagnosed with Prediabetes or Type 2 Diabetes Mellitus, defined as: 1) Pre-diabetic participants: HbA1c between 5.7 percentage to 6.4 percentage. 2) Diabetic participants: HbA1c Greater than or equal to 6.5 percentage. 3. Participants who are clinically stable and able to comply with study procedures. 4. Participants who are willing to maintain stable diet and lifestyle habits during the study period unless otherwise advised by the investigator. 5. Participants who are willing to avoid other herbal or alternative therapies intended for glycemic control during the study period unless approved by the investigator. 6. Participants who are willing and able to provide written informed consent. 7. Participants who are willing to comply with the study requirements, including completing all scheduled visits and questionnaire.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria: 1. Participant diagnosed with Type 1 diabetes. 2. Severely uncontrolled diabetes requiring immediate insulin therapy or hospitalization. 3. History of severe hypoglycemic episodes within the past 3 months. 4. Severe cardiovascular disease, including recent myocardial infarction, unstable angina, or uncontrolled hypertension. 5. Severe hepatic or renal impairment. 6. Known hypersensitivity or allergy to any ingredient of the investigational products. 7 Pregnant or lactating women, or women planning to become pregnant during the study period. 8. Current use of other herbal or investigational products intended for glycemic control within 30 days prior to screening. 9. Participation in another clinical trial within 3 months prior to screening. 10. History of drug or alcohol abuse or dependence within the past 5 years. 11. 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 HbA1c from Baseline Day 0 to Day 60 plus or minus 2 days 2.Change in Fasting Blood Glucose from Baseline Day 0 to Day 60 plus or minus 2 days 3.Assessment at Baseline Day 0 and Day 60 plus or minus 2 days 4.Clinically meaningful improvement includes reduction in HbA1c or reduction in fasting blood glucose or overall statistically significant improvement 5.Glycemic category improvement such as a. Type 2 Diabetes participants moving toward prediabetic or normal range b. Prediabetes participants moving toward normal glycemic levels Timepoint: Day 0 - visit 1 Day 30 2 days - visit 2 Day 60 2 days - visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are 1. Change in Quality of Life 1)Change in Diabetes Quality of Life (DQOL) Questionnaire total score from Baseline (Day 0) to End of Treatment (Day 60 ( 2 days)). 2)Assessment will be conducted at Baseline (Day 0), Day 30 ( 2 days) and End of Treatment (Day 60 ( 2 days)). 3)A clinically meaningful improvement will be defined as 1. Statistically significant improvement in mean DQOL total score from baseline to Day 60 ( 2 days), OR -2. Improvement in one or more domains of the DQOL questionnaire, including 3)Satisfaction with treatment 4)Impact of diabetes on daily life 5)Diabetes-related worries. Timepoint: Day 0 - visit 1 Day 30 2 days - visit 2 Day 60 2 days - visit 3;2. Safety and Tolerability 1) Incidence, type, severity, and causality of Adverse Events (AEs) reported throughout the study period. 2) Any Serious Adverse Events (SAEs) reported during the study. 3) Changes in vital signs (including systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and body temperature) from Baseline to Day 30 ( 2 days) and Day 60 ( 2 days). 4) Findings from physical examination at each study visit. 5) Investigator s overall safety and tolerability assessment during the study period. Timepoint: Day 0 - visit 1 Day 30 2 days - visit 2 Day 60 2 days - visit 3 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Sahyadri Ayurvedic Life Pvt Ltd.
Outcome results
None listed