Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2019-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Composite Interceptive Med Science
• Collaborator: Composite Interceptive Med-Science Laboratories Pvt Ltd

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:

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.