Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

NCT03787563 | Unknown DMC

• 1 other identifier: CIMED - 001- 2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Herbal Tea; Diabetes

Outcome Measures

Primary Outcomes (3)

• Fasting Plasma Glucose (FPG)

  Change from baseline in Fasting plasma glucose

  2 days and 5 days

• Oral Glucose Tolerance Test (OGTT)

  Change from baseline in OGTT

  2 days and 5 days

• 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.

  2 days and 5 days

Secondary Outcomes (1)

• Flash Glucose Measurements

  2 days and 5 days

Study Arms (2)

Active Herbal tea

ACTIVE COMPARATOR

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

Drug: Herbal Tea

Placebo Tea

PLACEBO COMPARATOR

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

Drug: Placebo Tea

Interventions

Herbal Tea DRUG

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.

Active Herbal tea

Placebo Tea DRUG

Similar looking inert placebo tea.

Placebo Tea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• h Post load Glucose ≥140 mg/dL during an OGTT. AND
• Glycosylated haemoglobin (A1C) ≥ 6.5 %.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Composite Interceptive Med Science: lead
• Composite Interceptive Med-Science Laboratories Pvt Ltd: collaborator

Study Sites (1)

Health India Hospital

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Teas, Herbal

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• HD Ramachandra Prabhu, MBBS, MD

  Health India Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjaya Chauhan, Pharm.D

CONTACT

09611252350; drsanjayachauhan49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded study
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: all the subjects will receive sequence of different study treatments.

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: December 26, 2018
• Study Start: January 1, 2019
• Primary Completion: January 15, 2019
• Study Completion: January 20, 2019
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

IN (1)