Table 2 Exclusion criteria. Exclusion criteria of the PURIAM110 trial

1.

Presently using other blood glucose level controlling agents.

2.

History of allergy to the herbal products (bitter oranges and Mulberry leaves) or allergic diseases such as asthma.

3.

Medication (within the last 1 month or during the study) which would affect the study results.

4.

Daily intake of alcoholic beverages.

5.

Smokers consuming more than 1 pack/day.

6.

Presently having acute diseases or other untreated illness requiring treatment.

7.

Impaired hepatic or renal functions.

8.

Pregnant, breast feeding status or female of reproductive age, not using proper contraception.

9.

Participant in other clinical trials or a blood donor, within the past 1 month.

10.

History of severe disease or any condition, in the investigator's opinion, that would endanger the individual's safety or affect the study result.

11.

Patients diagnosed as type I and type II diabetes mellitus(insulin requiring stage).