None listed
Conditions
Interventions
Intervention1: Diabliss Blood Glucose Management Herbal Supplement: 15 ml of Diabliss blood glucose management herbal supplement is mixed with 500 ml of water and Patients should consume this 500 ml s
Sponsors
Diabliss Consumer Products Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male/ Females subjects between 35-55 years of age 2. Subjects able to communicate effectively. 3. Subjects willing to provide written informed consent 4. In the judgment of the Principal Investigator, able to comply with protocol requirements. 5. Ability to schedule and attend monthly visits for the duration of the study. 6. Subjects with fasting blood glucose levels between 150-250 mg/dL 7. Subjects who are diabetic for one year with standard Diabetic medication 8. Subjects with HbA1C Levels (8% -10%)
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Contraindications or Hypersensitivity to study product. 2. History or presence of any medical condition or disease according to the discretion of the Investigator. 3. No contraindications to exercise as outlined by the American Endocrine society (ACS). 4. Patients with Fasting glucose levels more than 250 mg/dL. 5. Patients with diabetes associated with retinopathy 6. Patients with Diabetic Nephropathy and Diabetic Neuropathy 7. Patients with Chronic Cardiovascular diseases. 8. Subjects having abnormal findings on complete blood count 9. Subjects with HIV Positive. 10. Subjects having history of high alcohol intake (greater than 2 standard drinks per day). 11. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 12. Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures. 13. Subjects participated in any clinical study within thirty (30) days prior to screening. 14. Pregnant Women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: 1.Treatment satisfaction score 2.Treatment preference 3.Quality of life scores 4.Clinical and biochemical markers of Diabetes mellitusTimepoint: Day 0 to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study herbal supplement.Timepoint: Day 0 to Day 90 | — |
Countries
India
Contacts
Public ContactK Vihari
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD
Outcome results
None listed