A Clinical study to evaluate the efficacy and safety of Quista-DN health drink in diabetic individuals
Phase 2
- Conditions
- Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
- Registration Number
- CTRI/2019/07/020179
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br/ ><br>Visit 1- Screening <br/ ><br>Visit 2- Day 1 <br/ ><br>Visit 3- At the end of 1month (±4 days) <br/ ><br>Visit 4- At the end of 2 months (±4 days) <br/ ><br>Visit 5- (End of the study) At the end of 3months (±4 days) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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: <br/ ><br>Visit 1- Screening <br/ ><br>Visit 2- Day 1 <br/ ><br>Visit 3- At the end of 1month (±4 days) <br/ ><br>Visit 4- At the end of 2 months (±4 days) <br/ ><br>Visit 5- (End of the study) At the end of 3 months (±4 days) <br/ ><br>