Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
Conditions
Interventions
Intervention1: Quista_DN: A randomised open label clinical study to evaluate the safety and efficacy of Quista-DN health drink in diabetic and pre-diabetic individuals. Total of 40 subjects will be gi
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female subjects aged more than 18 years with FBS > 100 till 140 mg/dl and PPBS > 140 till 240 mg/dl or known Diabetic taking Oral hypoglycemic agents. 2. Subjects who have not participated in similar kind of study in last 4 weeks. 3. Individuals willing to sign informed consent and comply with the study procedure
Exclusion criteria
Exclusion criteria: • Women who are pregnant or nursing an infant or planning to conceive during the period of the study • Suffering from severe systemic and endocrinal disorders • Allergic to any ingredient in the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To maintain the blood sugar levels as compared to baseline And/ Or further helps in reducing blood sugar level to normal units (parameters namely FBS, PPBS and HbA1c).Timepoint: Patients will be followed up and the results will be assessed from baseline on visit days: Visit 1- Screening Visit 2- Day 1 Visit 3- At the end of 1month (±4 days) Visit 4- At the end of 2 months (±4 days) Visit 5- (End of the study) At the end of 3months (±4 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify the incidence of adverse effects of the product and compliance to the study formulation.Timepoint: Patients will be followed up and the results will be assessed from baseline on visit days: Visit 1- Screening Visit 2- Day 1 Visit 3- At the end of 1month (±4 days) Visit 4- At the end of 2 months (±4 days) Visit 5- (End of the study) At the end of 3 months (±4 days) | — |
Countries
India
Contacts
Public ContactDr Palaniyamma
The Himalaya Drug Company
Outcome results
None listed