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Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03787563
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Composite Interceptive Med-Science Laboratories Pvt Ltd
Information provided by (Responsible Party):
Composite Interceptive Med Science

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Herbal Tea Drug: Placebo Tea Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: all the subjects will receive sequence of different study treatments.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blinded study
Primary Purpose: Supportive Care
Official Title: Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Herbal tea
One tea bag infusion three times a day each before breakfast, lunch and dinner.
Drug: 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 Comparator: Placebo Tea
Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
Drug: Placebo Tea
Similar looking inert placebo tea.




Primary Outcome Measures :
  1. Fasting Plasma Glucose (FPG) [ Time Frame: 2 days and 5 days ]
    Change from baseline in Fasting plasma glucose

  2. Oral Glucose Tolerance Test (OGTT) [ Time Frame: 2 days and 5 days ]
    Change from baseline in OGTT

  3. 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.


Secondary Outcome Measures :
  1. Flash Glucose Measurements [ Time Frame: 2 days and 5 days ]
    Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787563


Contacts
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Contact: Sanjaya Chauhan, Pharm.D 09611252350 drsanjayachauhan49@gmail.com

Locations
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India
Health India Hospital Not yet recruiting
Bangalore, Karnataka, India, 560029
Contact: Thirumalesha RL, BAMS         
Sponsors and Collaborators
Composite Interceptive Med Science
Composite Interceptive Med-Science Laboratories Pvt Ltd
Investigators
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Principal Investigator: HD Ramachandra Prabhu, MBBS, MD Health India Hospital

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Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT03787563     History of Changes
Other Study ID Numbers: CIMED - 001- 2018
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Composite Interceptive Med Science:
Herbal Tea
Diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases