Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03787563
• Other study ID #: CIMED - 001- 2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 20, 2019

Study information

• Verified date: December 2018
• Source: Composite Interceptive Med Science
• Contact: Sanjaya Chauhan, Pharm.D
• Phone: 09611252350
• Email: drsanjayachauhan49[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 20, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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 Tea
Similar looking inert placebo tea.

Locations

Country	Name	City	State
India	Health India Hospital	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Composite Interceptive Med Science	Composite Interceptive Med-Science Laboratories Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose (FPG)	Change from baseline in Fasting plasma glucose	2 days and 5 days
Primary	Oral Glucose Tolerance Test (OGTT)	Change from baseline in OGTT	2 days and 5 days
Primary	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	Flash Glucose Measurements	Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor	2 days and 5 days