Herbal Tea in the Treatment of Type 2 Diabetes Mellitus
NCT ID: NCT03787563
Last Updated: 2018-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-01-01
2019-01-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Active Herbal tea
One tea bag infusion three times a day each before breakfast, lunch and dinner.
Herbal 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.
Placebo Tea
Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
Placebo Tea
Similar looking inert placebo tea.
Interventions
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Herbal 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.
Placebo Tea
Similar looking inert placebo tea.
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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Composite Interceptive Med-Science Laboratories Pvt Ltd
UNKNOWN
Composite Interceptive Med Science
INDUSTRY
Responsible Party
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Principal Investigators
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HD Ramachandra Prabhu, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
Health India Hospital
Locations
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Health India Hospital
Bangalore, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Thirumalesha RL, BAMS
Role: primary
Other Identifiers
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CIMED - 001- 2018
Identifier Type: -
Identifier Source: org_study_id