Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Herbal Tea: All participants will be given the intervention in
an infusion tea bag. Participant will be instructed
to take one tea bag three times a day at before
breakfast, lunch and d
Sponsors
Composite Interceptive MedScience Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria 1. Fasting Plasma Glucose >=126 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND 2. 2-h Post load Glucose >=140 mg/dL during an OGTT. AND 3. Glycosylated haemoglobin (A1C) >= 6.5 %.
Exclusion criteria
Exclusion criteria: Any one of the following 1. Patients on Insulin therapy. 2. Patients on oral hypoglycemic agents other than metformin 3. Any history suggestive of micro vascular or macro vascular disease â??coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes. 4. Women in child bearing age unable to practice any form of contraception 5. Patients with diagnosis of Anaemia (Hemoglobin 6. Impaired renal function; estimated glomerular function 7. Known history of any chronic illness taking regular pharmacological agents. 8. Blood pressure fluctuations exceeding 20 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 3 or more antihypertensive medications regularly in the last 6 weeks 9. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy 10. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Fasting plasma glucose and oral glucose tolerance test(OGTT)Timepoint: 2 days and 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensorTimepoint: 2 days and 5 days;Number of Subject with adverse eventsTimepoint: 2 days and 5 days | — |
Countries
India
Contacts
Public ContactDr Sanjaya Chauhan
Composite Interceptive Med Science
Outcome results
None listed