Herbal Tea in the Treatment of Type 2 diabetes mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/01/016953
- Lead Sponsor
- Composite Interceptive MedScience Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 %.
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 <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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Fasting plasma glucose and oral glucose tolerance test(OGTT)Timepoint: 2 days and 5 days
- Secondary Outcome Measures
Name Time Method 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