Efficacy of Micon Gold Capsule in Diabetes

Not Applicable

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Brief Summary: Post-marketing open label observational clinical study will be undertaken by investigator and his teams in Kolkata at 2 sites. Total no. of study patients 30 + 10% probable dropouts. Only those patients providing written informed consent will be enrolled for the study in specific centre. After receiving written consent, all patient will be assessed according to inclusion and exclusion criteria and then will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Patients will be orally administered Micon Gold Capsule - 2 cap twice daily before food with lukewarm water for 90 days. Diet habit/ life style modification will also be guided. The patients will visit their specific centre at baseline and at end of the study for assessment. Statistical analysis will be done according to type of data and significance will be considered p less than 0.05.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
1.Assessment Questionnaire	1.Assessment Questionnaire \| 2.Blood tests: FBG, PPBG, HbA1c \| (From Baseline to 90 days of treatment)
(From Baseline to 90 days of treatment)	1.Assessment Questionnaire \| 2.Blood tests: FBG, PPBG, HbA1c \| (From Baseline to 90 days of treatment)
2.Blood tests: FBG, PPBG, HbA1c	1.Assessment Questionnaire \| 2.Blood tests: FBG, PPBG, HbA1c \| (From Baseline to 90 days of treatment)

Secondary Outcome Measures

Name	Time	Method
1.Quality of Life	2.Drug safety: RFT & LFT

Locations (2): RB Diagnostic Pvt Ltd
🇮🇳
Kolkata, WEST BENGAL, India
The Ayurveda Clinic and Research Centre
🇮🇳
Kolkata, WEST BENGAL, India
RB Diagnostic Pvt Ltd
🇮🇳Kolkata, WEST BENGAL, India
Dr A K Jain
Principal investigator
7044517791
dr.jainak00@gmail.com