Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: LactoSpore®: One capsule once a day before food for a period of 90 days.
Control Intervention1: Placebo: One capsule once a day before food for a period of 90 days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients with Dyslipidaemia and Type II Diabetes. 2 Age between 30 to 65 years. 3 Glucosylated haemoglobin level greater than equal to 6.6% and less than equal to 9.0% and total cholesterol greater than equal to 200mg/dl and less than equal to 239 mg/dl. 4 Have not consumed any probiotic for the last 2 months prior to recruitment. 5 Ability to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1 Pregnant women,nursing mothers or subject who does not agree to assigned contraception in the study. 2 History of acute or chronic illness such as cancer or rheumatoid arthritis. 3 Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase. 4 Participation in a clinical study during the preceding 90 days. 5 Any contraindication to blood sampling. 6 Patients using yogurt in their daily meal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Myeloperoxidase 2 Lipid Profile 3 Diabetic Profile 4 PAC-Quality of Life QuestionnaireTimepoint: 1 Myeloperoxidase(Day0 & Day90) 2 Lipid Profile(Screening,Day45 & Day90) 3 Diabetic Profile(Screening,Day45 & Day90)) 4 PAC-Quality of Life Questionnaire(Day0,Day45 & Day90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse events. 2 Vital Signs. 3 Laboratory parameters. Timepoint: 1 Adverse events(Day45 & Day90 2 Vital Signs(All visits). 3 Laboratory parameters(Screening,Day45 & Day90). | — |
Countries
India
Contacts
Public ContactMr Hasan Ahmed
ClinWorld Private Limited
Outcome results
None listed