Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Unani Medicine (CCRUM)
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients within the age range of 30 and 65 years of age diagnosed with T2DM for at least 6 months. Participants with fasting plasma glucose greater than or equal to 126 mg/dL or random plasma glucose greater than 200 mg/dL. Participants with an HbA1c value of 6.5 8 percent. Willingness to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Type 1 Diabetes Mellitus HbA1c greater than eight percent. Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological, or respiratory disorders, in the view of the investigator. Patients with psychiatric disorder. History of smoking more than ten cigarettes per day or alcohol intake greater than twenty grams per day. History or evidence suggestive of complications of diabetes such as retinopathy, nephropathy, or ischemic heart disease with any cardiac event in the last six months. Body mass index greater than thirty five kilograms per square meter or less than twenty kilograms per square meter. Patients who are likely to undergo surgery during the study period. Patients who have participated in any investigational study in the last twelve weeks. Known hypersensitivity to the study drugs. Patients with severe infection, in the view of the investigator. History of intake of any Ayurvedic, herbal, homeopathic, or dietary supplements in the last two months. Pregnant or nursing mothers and women of childbearing age refusing to use contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the reduction of blood sugar levels. To measure the reduction of HbA1c levels. To Compare the severity assessment between two groups. Timepoint: To measure the reduction of blood sugar levels from baseline (Day 0) till the end of the study (Day 180). To measure the reduction of HbA1c levels from baseline (Day 0) till the end of the study (Day 180). To Compare the severity assessment between two groups from baseline (Day 0) till the end of the study (Day 180). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in safety parameters. To assess the safety and tolerability of the drug. Timepoint: To assess the change in safety parameters from baseline (Day 0) till the end of the study (Day 180). To assess the safety and tolerability of the drug from baseline (Day 0) till the end of the study (Day 180). | — |
Countries
India
Contacts
Public ContactDr Mothishwaran B
SRM Institute of Science and Technology
Outcome results
None listed