Date

2022-11-28

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

Diagnosis of other illness such as GIT, Hepatic, Renal, Endocrine disorders according to Siddha diagnostic criteria. Patients on allopathic drugs Presence of complication of the diabetes mellitus (chronic wounds, renal disease, eye disease and peripheral neuropathy) Insulin dependent diabetes mellitus Those unwilling to come for regular follow - up for the entire duration of the study and any subjects considered not eligible according to the researcher’s discretion. Pregnancy Breast feeding Having child bearing potential (Age below 45 who are not on regular contraception)

Next Version

Subjects who were suffering from other illness such as gastro intestinal disorders, hepatic disorders, renal disorders, and endocrine disorders, taking allopathic drugs, Type I Diabetes patients, women who are pregnant and lactating and with detectable or visible clinical complication were excluded from this study.