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Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Herbal Tea

Placebo Tea

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Herbal Tea, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Health India Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Herbal tea

Placebo Tea

Arm Description

One tea bag infusion three times a day each before breakfast, lunch and dinner.

Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.

Outcomes

Primary Outcome Measures

Fasting Plasma Glucose (FPG)

Change from baseline in Fasting plasma glucose

Oral Glucose Tolerance Test (OGTT)

Change from baseline in OGTT

Number of Subject with adverse events

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

Flash Glucose Measurements

Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor

Full Information

NCT ID

NCT03787563

First Posted

December 23, 2018

Last Updated

December 23, 2018

Sponsor

Composite Interceptive Med Science

Collaborators

Composite Interceptive Med-Science Laboratories Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03787563

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Anticipated)

Primary Completion Date

January 15, 2019 (Anticipated)

Study Completion Date

January 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Composite Interceptive Med Science

Collaborators

Composite Interceptive Med-Science Laboratories Pvt Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Herbal Tea, Diabetes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

all the subjects will receive sequence of different study treatments.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double blinded study

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Herbal tea

Arm Type

Active Comparator

Arm Description

One tea bag infusion three times a day each before breakfast, lunch and dinner.

Arm Title

Placebo Tea

Arm Type

Placebo Comparator

Arm Description

Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.

Intervention Type

Drug

Intervention Name(s)

Herbal Tea

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo Tea

Intervention Description

Similar looking inert placebo tea.

Primary Outcome Measure Information:

Title

Fasting Plasma Glucose (FPG)

Description

Change from baseline in Fasting plasma glucose

Time Frame

2 days and 5 days

Title

Oral Glucose Tolerance Test (OGTT)

Description

Change from baseline in OGTT

Time Frame

2 days and 5 days

Title

Number of Subject with adverse events

Description

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.

Time Frame

2 days and 5 days

Secondary Outcome Measure Information:

Title

Flash Glucose Measurements

Description

Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor

Time Frame

2 days and 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sanjaya Chauhan, Pharm.D

Phone

09611252350

drsanjayachauhan49@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HD Ramachandra Prabhu, MBBS, MD

Organizational Affiliation

Health India Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Health India Hospital

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560029

Country

India

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thirumalesha RL, BAMS

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

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