Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Group A: Health supplement + Oral hypoglycemic agents (OHA).
: Take 10 ml twice daily, one hour before lunch and dinner, with water for 90 days
Control Intervention1: Group B: Placebo
Sponsors
Nutrifeel Health Products Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 30 and 65 years (both inclusive) 2. Participants receiving oral hypoglycemic agents, biguanides, and sulfonylureas (Only combination) 3. Glycated hemoglobin (HbA1c) greater than 7% and less than 9 % ( both inclusive) 4. Participants willing to comply with the study procedure and sign the written informed consent 5. Participants with a BMI of less than 30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Participant with Type 1 diabetes mellitus; 2. Participant taking antidiabetic drugs except for those specified in the inclusion criteria, including Insulin treatment; 3. Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT more than 3 times the upper normal limit) or renal dysfunction (defined as S. creatinine greater than 1.4 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients), or other concurrent severe disease 4. Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment 5. Participants who are smokers/alcoholics and/or known drug abusers 6. Participants with evidence or history of malignancy 7. Participant enrolled in any other clinical trial requiring drug therapy 8. Pregnant or lactating women or women of fertile age not using effective contraception 9. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in HbA1c levels and Fasting and post-meal plasma glucose will be done 2. Assessment of changes in insulin resistance (HOMA-IR) will be assessed Timepoint: 1.at screening and day 90 and baseline, day 30, day 60, and day 90. 2.at the baseline and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of change in lipid profile will be done 2. Assessment of changes in metabolic syndrome severity Z score (MetS Z score) will be assessed 3. Assessment of change in anthropometric parameters will be performed 4. Assessment of changes in serum C-reactive protein (CRP) levels will be assessed 5. Assessment of change in fatigue severity scale score (FSS) will be done 6. Assessment of change in diabetes related quality of life by DQOL will be done Timepoint: 1.at baseline and day 90. 2.at baseline and day 90. 3.at screening, day 30, day 60, and day 90. 4. at the baseline and day 90 5. at baseline, day 30, day 60, and day 90. 6. at the baseline and day 90. | — |
Countries
India
Contacts
Public ContactSadik Shaikh
Improva Herbal Products
Outcome results
None listed