Health Condition 1: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: Integrated Ayurveda, Naturoapthy and Yoga: Participants in the intervention group will continue with an integrative intervention program consisting of Ayurvedic management, naturopathy
Sponsors
Patanjali Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Individuals diagnosed with Type-1 Diabetes Mellitus according to standard clinical criteria and receiving insulin therapy. 2.Male and Female aged between 18 and 45 years. 3.Patients with HbA1c between 7% and 10% indicating suboptimal glycemic control but clinically stable condition. 4.Individuals who are willing to participate in the study and provide written informed consent. 5.Participants who are willing to comply with the prescribed integrative intervention protocol and follow-up schedule.
Exclusion criteria
Exclusion criteria: 1.Individuals with Type-2 diabetes mellitus, gestational diabetes, or other specific types of diabetes. 2.Patients with severe diabetic complications such as advanced nephropathy, proliferative retinopathy, severe neuropathy, or history of recurrent diabetic ketoacidosis. 3.Individuals with major systemic illnesses such as severe cardiovascular disease, chronic liver disease, or malignancy. 4.Participants currently undergoing other structured lifestyle intervention programs or clinical trials that may influence study outcomes. 5.Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycemic Control as assessed by fasting blood sugar (FBS), postprandial blood sugar (PPBS), and glycated hemoglobin (HbA1c) from baseline to Week 12. Change in Daily Insulin Requirement measured as total daily insulin dose (units/day or units/kg/day) from baseline to Week 12. Change in Quality of Life assessed using the Diabetes Quality of Life (DQOL) questionnaire from baseline to Week 12.Timepoint: Eligible participants will be screened and enrolled after obtaining written informed consent. Randomization/allocation will be performed at baseline (Week 0). The Integrative Ayurveda Naturopathy Yoga intervention and standard care (including insulin therapy, dietary advice, and physical activity recommendations) will be initiated at baseline and continued throughout the study period up to Week 12. Demographic characteristics will be recorded at baseline only. Anthropometric parameters (weight, body mass index, and waist circumference), fasting blood sugar (FBS), postprandial blood sugar (PPBS), and 24-hour dietary recall assessments will be conducted at baseline, during the residential intervention phase (Weeks 1 3 or at discharge), and at follow-up visits scheduled at Weeks 6, 9, and 12. Glycated hemoglobin (HbA1c) will be assessed at baseline and at the end of the intervention period (Week 12). Adverse events and safety parameters will be monitored continuously from baseline through the residential phase and all follow-up visits until study completion at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Anthropometric Parameters including body weight, body mass index (BMI), waist circumference, and waist hip ratio from baseline to Week 12. Change in Physical Activity Levels assessed using the International Physical Activity Questionnaire Short Form (IPAQ SF) from baseline to Week 12. Change in Dietary Patterns and Lifestyle Practices assessed through 24 hour dietary recall and adherence to prescribed lifestyle recommendations during the study period. Change in Psychological Well Being and Perceived Stress Levels from baseline to Week 12. Improvement in Metabolic Health and Physiological Balance as reflected by trends in glycemic parameters, anthropometric measures, and exploratory metabolic indicators assessed during the study. Safety and Tolerability of the Integrative Intervention assessed through monitoring and recording of adverse events throughout the study period.Timepoint: Eligible participants will be screened and enrolled after obtaining written informed consent. Randomization/allocation will be performed at baseline (Week 0). The Integrative Ayurveda Naturopathy Yoga intervention and standard care (including insulin therapy, dietary advice, and physical activity recommendations) will be initiated at baseline and continued throughout the study period up to Week 12. Demographic characteristics will be recorded at baseline only. Anthropometric parameters (weight, body mass index, and waist circumference), fasting blood sugar (FBS), postprandial blood sugar (PPBS), and 24-hour dietary recall assessments will be conducted at baseline, during the residential intervention phase (Weeks 1 3 or at discharge), and at follow-up visits scheduled at Weeks 6, 9, and 12. Glycated hemoglobin (HbA1c) will be assessed at baseline and at the end of the intervention period (Week 12). Adverse events and safety parameters will be monitored continuously from baseline through the residential phase and all follow-up visits until study completion at Week 12. | — |
Countries
India
Contacts
Public ContactDr Canchi B Dhanraj
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar-249405
Outcome results
None listed