Clinical trial NCT03787563: Herbal Tea in the Treatment of Type 2 Diabetes Mellitus
Official title: Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Herbal Tea
Diabetes
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
Collaborators: name: Composite Interceptive Med-Science Laboratories Pvt Ltd
First posted: 2018-12-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: all the subjects will receive sequence of different study treatments.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: 2 days and 5 days
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: 2 days and 5 days
measure: Number of Subject with adverse events
timeFrame: 2 days and 5 days
Secondary outcomes:
measure: Flash Glucose Measurements
timeFrame: 2 days and 5 days
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Health India Hospital
state: Karnataka
Study officials:
affiliation: Health India Hospital
name: HD Ramachandra Prabhu, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: