An interventional study of Herbal Tea and Placebo Tea in Type 2 Diabetes Mellitus, sponsored by Composite Interceptive Med Science. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Composite Interceptive Med Science · Not applicable, Interventional, and Supportive care
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Composite Interceptive Med Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria
Exclusion Criteria:
Any one of the following
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One tea bag infusion three times a day each before breakfast, lunch and dinner.
Drug: Herbal Tea
Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
Drug: Placebo 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.
Similar looking inert placebo tea.
Fasting Plasma Glucose (FPG)
Change from baseline in Fasting plasma glucose
Time frame: 2 days and 5 days
Oral Glucose Tolerance Test (OGTT)
Change from baseline in OGTT
Time frame: 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.
Time frame: 2 days and 5 days
Flash Glucose Measurements
Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor
Time frame: 2 days and 5 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Composite Interceptive Med Science