Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: KAL-10 meal (Food product): 03 scoops KAL-10 mealwith morning meal,After noon and evening meal daily for a period of 12 weeks
Control Intervention1: Not applicable (Single arm study): N
Sponsors
Kerala Ayurveda Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the age group of 18 to 60 years, both inclusive. 2. Patients suffering from Type II Diabetes Mellitus for more than one year, and stabilized on mono / poly oral hypoglycemic drug underanti-diabetic therapy. 3. Patients having HbA1c value below 8% at screening. 4. Patients of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal. 5. Patients who willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Type-I & Type-II Diabetic patients who are on Insulin. 2. Known cases of severe/chronic hepatic or renal disease. 3. Known patient of any active malignancy. 4. Patients giving history of significant cardiovascular event 5. Patients having history of known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 6. Patients having history of known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 7. Known patients of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 8. Patients using any other investigational drug within 1 month prior to recruitment 9. Patients currently participating in any other clinical study 10. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the effect of KAL-10 meal by observing changes on FBG and PPG and lipid profile after 12 weeks intake of KAL-10 meal 2. Evaluate Changes in glucose level by continuous glucose monitoring for 2 weeks following intake of KAL-10 meal in a subset from the baseline. 3. Evaluate changes in weight, body mass index after 12 week intake of KAL-10 meal Timepoint: Baseline to Week 12 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate changes in level of HbA1c after 12 weeks intake of KAL-10 mealTimepoint: Base line and Week 12 | — |
Countries
India
Contacts
Public ContactJayashree M
Kerala Ayurveda Limited
Outcome results
None listed