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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Herbal Tea Drug: Placebo Tea||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
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.
- Fasting Plasma Glucose (FPG) [ Time Frame: 2 days and 5 days ]Change from baseline in Fasting plasma glucose
- Oral Glucose Tolerance Test (OGTT) [ Time Frame: 2 days and 5 days ]Change from baseline in OGTT
- 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.
- Flash Glucose Measurements [ Time Frame: 2 days and 5 days ]Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787563
|Contact: Sanjaya Chauhan, Pharm.Dfirstname.lastname@example.org|
|Health India Hospital||Not yet recruiting|
|Bangalore, Karnataka, India, 560029|
|Contact: Thirumalesha RL, BAMS|
|Principal Investigator:||HD Ramachandra Prabhu, MBBS, MD||Health India Hospital|