Health Condition 1: F411- Generalized anxiety disorder Health Condition 2: M255- Pain in joint Health Condition 3: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Every Participants should fulfill the following eligibility criteria to participate in the study: 1. Patients of either sex between the age 18 to 65 years. 2. Patients with Type II Diabetes mellitus, who are under Oral anti hyperglycemic drugs on a regular basis and whose random blood glucose level is = 250mg/dl. 3. Type II Diabetic patients associated with Generalized Anxiety Disorder and Joint Pain. 4. Patients who fulfill DSM IV and ICD-10 diagnostic criteria for GAD will be included in the study. 5. Sustention of Chronic musculoskeletal pain due to osteoarthritis, lower back pain, rheumatic arthritis, neck shoulder-arm syndrome, diabetic neuropathy for at least minimum of 3 months or even more.
Exclusion criteria
Exclusion criteria: The following will be excluded from the study: 1. Uncontrolled Type II Diabetic mellitus though on Oral anti-hyperglycemic drugs i.e., = 250mg/dl. 2. Patients with joint deformities. 3. Patients with co-morbid psychiatric disorders. 4. Patients with any other psychiatric diagnosis other than GAD. 5. Patients who are on regular treatment with psychotropic drugs at least four weeks prior to the study. 6. Patients who are substance abuse like alcohol, drugs etc., 7. Patients who are diagnosed with significant depression. 8. Patients with other complicated medical conditions as per the investigator discretion are excluded from the study. 9. Pregnant or lactating females and women in childbearing age refusing to use double barrier contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To observe how Parsana Acupressure Therapy Plate acts against increase in blood glucose levels in Type-II Diabetic patients. 2. To observe clinically, the anti-anxiety effect of Parsana Acupressure Therapy Plate. 3. To also observe the effect of Parsana Acupressure therapy plate in chronic musculoskeletal pains. 4. To assess changes in hormonal levels in blood in relation with Dopamine, Serotonin & Cortisol hormonesTimepoint: Day 0 Day 1 Day 15 Day 30 Day 45 Day 60 Day 75 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety profile & overall compliance. 2. Self-reported AEs & SAEs. Timepoint: Day 0 Day 1 Day 15 Day 30 Day 45 Day 60 Day 75 Day 90 | — |
Countries
India
Contacts
TrialGuna Private Limited