Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Herbal Tea; Drug: Placebo Tea

• Registration Number: NCT03787563
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2018-12-23
• Last Update Submitted: 2018-12-23
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26
• Study Start: 2019-01-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Herbal tea	Herbal Tea	One tea bag infusion three times a day each before breakfast, lunch and dinner.
Placebo Tea	Placebo Tea	Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.

Primary Outcome Measures

Name	Time	Method
Oral Glucose Tolerance Test (OGTT)	2 days and 5 days	Change from baseline in OGTT
Fasting Plasma Glucose (FPG)	2 days and 5 days	Change from baseline in Fasting plasma glucose
Number of Subject with adverse events	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

Name	Time	Method
Flash Glucose Measurements	2 days and 5 days	Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor

Trial Locations

Locations (1)

Health India Hospital; 🇮🇳 Bangalore, Karnataka, India