Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed T2DM patients aged 18-65 years with - Expressions of anxiety within mild to moderate as assessed by Hamilton Anxiety Rating Scale (HAM-A) score 1 to 24 with duration of 2 weeks to 6 months. - Expressions of Depression within mild to moderate as assessed by Hamilton Depression Rating Scale (HAM-D) score between 8 to 24 with duration of 2 weeks to 3 months. - Who are on standard of care for management of diabetes for past 3 months, with HbA1c levels 6.5 % - 9.5% - Not currently undergoing other forms of psychological or psychiatric treatment. - Both Genders willing to give written consent for the part of this study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in severity of anxiety or depression from baseline to 12 months, assessed using: Hamilton Anxiety Rating Scale (HAM-A) score OR Hamilton Depression Rating Scale (HAM-D) score (Comparison between intervention and control group)Timepoint: Glycaemic Control: Fasting blood sugar (FBS) levels monthly once for 1st 3 months after allocation, followed by once in 3 months. Postprandial blood sugar (PPBS) levels- monthly once for 1st 3 months after allocation, followed by once in 3 months. HbA1c levels - once in 6 months. Anxiety or Depression Scores: HAM-A scores for anxiety (after 3rd, 6th ,9th and 12th month). Or HAM-D scores for depression (after 3rd, 6th, 9th and 12th month). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in glycaemic control parameters: Fasting Blood Sugar (FBS) Post-Prandial Blood Sugar (PPBS) HbA1c Correlation between change in HAM-A / HAM-D scores and: FBS PPBS HbA1c Requirement/modification of oral hypoglycaemic agents during study period.Timepoint: from baseline to 12 months | — |
Countries
India
Contacts
Father Muller Homoeopathic Medical College and Hospital