Status:
UNKNOWN
Herbal Tea in the Treatment of Type 2 Diabetes Mellitus
Lead Sponsor:
Composite Interceptive Med Science
Collaborating Sponsors:
Composite Interceptive Med-Science Laboratories Pvt Ltd
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria
- Fasting Plasma Glucose ≥126 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
- 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND
- Glycosylated haemoglobin (A1C) ≥ 6.5 %.
Exclusion
- Any one of the following
- Patients on Insulin therapy.
- Patients on oral hypoglycemic agents other than metformin
- Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
- Women in child bearing age unable to practice any form of contraception
- Patients with diagnosis of Anaemia (Hemoglobin \<11 g/dl in Female and \<13 g/dl in Male)
- Impaired renal function; estimated glomerular function \<60mls/min/1.73m2.
- Known history of any chronic illness taking regular pharmacological agents.
- 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
- Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
- Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03787563
Start Date
January 1 2019
End Date
January 20 2019
Last Update
December 26 2018
Active Locations (1)
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1
Health India Hospital
Bangalore, Karnataka, India, 560029