Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: AS GEL: Test Product, Dose, And Route of Administration Test product: AS GEL
Dose: 15 grams of gel daily
Dosage form: Gel
Frequency: Once daily 30 mins. after a meal for 8 weeks.
Route
Sponsors
PR Nine Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female elderly individuals aged 35-75 (both inclusive). 2. Patients diagnosed with Diabetes Mellitus from the past two years. 3. Patients who give consent for participation in the study. 4. Patients with a BMI more than 23(Kg/m2)
Exclusion criteria
Exclusion criteria: 1. Treatment with insulin within the last 3 months before the trial. 2. Impaired liver or/and renal function. 3. Patients having an allergy to oral moisturizing creams. 4. Patients who had a salivary gland removal, and patients with Sjogrens syndrome. 5. Patients having chronic complications of Diabetes, Retinopathy, Neuropathy and Nephropathy. 6. Patients with the Presence of any oral mucosal lesion. 7. Those with pregnant or lactating, or women of childbearing age who do not agree to use medication during the trial. 8. Participants who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period. 9. Those who are deemed unable to comply with the test requirements or otherwise considered as unsuitable according to the investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) HbA1c 2) Fasting Blood Glucose levels.Timepoint: Baseline,10th Week | — |
Secondary
| Measure | Time frame |
|---|---|
| CODS Index(Clinical Oral Dryness Score)Timepoint: Baseline,10th Week;Challacombe scaleTimepoint: Baseline,10th Week;Xerostomia Inventory.Timepoint: Baseline,10th Week | — |
Countries
India
Contacts
Public ContactDr Bhargav Bhongiri
Syncorp Health Pvt. Ltd.
Outcome results
None listed