Type 2 Diabetes Mellitus
Conditions
Keywords
Herbal Tea, Diabetes
Brief summary
Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It has become a major healthcare problem in India. High-quality, low-cost solutions adapted to the local context are critical to addressing the current crisis in the management of diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering properties.The aim of this trial is to study the effect of a herbal tea in the glycemic response in the early type 2 diabetes.
Interventions
DRUGHerbal 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 dinner meals. At the time of randomization both active and placebo infusion bag will be provided.There will be one day of washout period after 2 days on treatment.
DRUGPlacebo Tea
Similar looking inert placebo tea.
Sponsors
Composite Interceptive Med-Science Laboratories Pvt Ltd
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blinded study
Intervention model description
all the subjects will receive sequence of different study treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 - 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 \<11 g/dl in Female and \<13 g/dl in Male) 6. Impaired renal function; estimated glomerular function \<60mls/min/1.73m2. 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 | Description |
|---|---|---|
| Fasting Plasma Glucose (FPG) | 2 days and 5 days | Change from baseline in Fasting plasma glucose |
| Oral Glucose Tolerance Test (OGTT) | 2 days and 5 days | Change from baseline in OGTT |
| Number of Subject with adverse events | 2 days and 5 days | Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flash Glucose Measurements | 2 days and 5 days | Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor |
Countries
India
Contacts
Primary ContactSanjaya Chauhan, Pharm.D
Outcome results
None listed