Efficacy of Micon Gold Capsule in Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/02/049894
- Lead Sponsor
- Med Pharma CRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients 25 years or older, with Type 2 Diabetes Mellitus confirmed by WHO criteria for type 2 diabetes
2.Patients freshly diagnosed as diabetics or those who were on oral hypoglycemic agents without insulin
3.Patients willing to give written informed consent.
4.Patients are fit and no need for any hospital administration.
5.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.
1.Patients with renal impairment.
2.Patients will be also excluded if they have poorly controlled diabetes mellitus.
3.Female patients who are pregnant.
4.Unstable medical or psychiatric illness.
5.Chronic & acute disorders requiring hospital admission.
6.Known HIV-positive, Hepatitis B or C status.
7.Inability to carry out visits for the study.
8.Inability to maintain current medication regimen.
9.Inability or unwillingness to participate in all components of the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Assessment Questionnaire <br/ ><br>2.Blood tests: FBG, PPBG, HbA1c <br/ ><br>(From Baseline to 90 days of treatment)Timepoint: 1.Assessment Questionnaire <br/ ><br>2.Blood tests: FBG, PPBG, HbA1c <br/ ><br>(From Baseline to 90 days of treatment)
- Secondary Outcome Measures
Name Time Method 1.Quality of Life <br/ ><br>2.Drug safety: RFT & LFT <br/ ><br>3.Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period <br/ ><br>(From Baseline to 90 days of treatment)Timepoint: From Baseline to 90 days of treatment