- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03787563
Herbal Tea in the Treatment of Type 2 Diabetes Mellitus
December 23, 2018 updated by: Composite Interceptive Med Science
Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sanjaya Chauhan, Pharm.D
- Phone Number: 09611252350
- Email: drsanjayachauhan49@gmail.com
Study Locations
-
-
Karnataka
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Bangalore, Karnataka, India, 560029
- Health India Hospital
-
Contact:
- Thirumalesha RL, BAMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Herbal tea
One tea bag infusion three times a day each before breakfast, lunch and dinner.
|
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 Comparator: Placebo Tea
Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
|
Similar looking inert placebo tea.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Plasma Glucose (FPG)
Time Frame: 2 days and 5 days
|
Change from baseline in Fasting plasma glucose
|
2 days and 5 days
|
Oral Glucose Tolerance Test (OGTT)
Time Frame: 2 days and 5 days
|
Change from baseline in OGTT
|
2 days and 5 days
|
Number of Subject with adverse events
Time Frame: 2 days and 5 days
|
Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.
|
2 days and 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flash Glucose Measurements
Time Frame: 2 days and 5 days
|
Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor
|
2 days and 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: HD Ramachandra Prabhu, MBBS, MD, Health India Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
January 15, 2019
Study Completion (Anticipated)
January 20, 2019
Study Registration Dates
First Submitted
December 23, 2018
First Submitted That Met QC Criteria
December 23, 2018
First Posted (Actual)
December 26, 2018
Study Record Updates
Last Update Posted (Actual)
December 26, 2018
Last Update Submitted That Met QC Criteria
December 23, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIMED - 001- 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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