Type 2 Diabetes MellitusNCT03787563
Herbal Tea in the Treatment of Type 2 Diabetes Mellitus
A study testing Herbal Tea in people with Type 2 Diabetes Mellitus, run by Composite Interceptive Med Science at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Herbal Tea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 20 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND
- Glycosylated haemoglobin (A1C) ≥ 6.5 %.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Health India Hospital
Bangalore, Karnataka, 560029
Thirumalesha RL, BAMS
About this study
Official title: Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
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
- Being tested
- Herbal Tea, Placebo Tea
- Keywords
- Herbal Tea, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal TeaDrug
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 TeaDrug
Similar looking inert placebo tea.
| Study group | Role | What they receive |
|---|---|---|
| Active Herbal tea | Active comparator | One tea bag infusion three times a day each before breakfast, lunch and dinner. Receives: Drug: Herbal Tea |
| Placebo Tea | Placebo comparator | Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner. Receives: Drug: Placebo Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose (FPG)
Change from baseline in Fasting plasma glucose
Measured: 2 days and 5 days
Oral Glucose Tolerance Test (OGTT)
Change from baseline in OGTT
Measured: 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.
Measured: 2 days and 5 days
Secondary outcomes (1)
Flash Glucose Measurements
Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor
Measured: 2 days and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion15 Jan 2019 (estimated)
- Study completion20 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- all the subjects will receive sequence of different study treatments.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Composite Interceptive Med-Science Laboratories Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- HD Ramachandra Prabhu, MBBS, MD, Principal investigator, Health India Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787563
- Sponsor's protocol ID
- CIMED - 001- 2018
- Status last verified
- Dec 2018
- First submitted
- 23 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03787563
- Acronym / sponsor ID
- CIMED - 001- 2018
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Herbal Tea, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Collaborators
- Composite Interceptive Med-Science Laboratories Pvt Ltd
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 20 Jan 2019 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- all the subjects will receive sequence of different study treatments.
| Arm | Type | Receives |
|---|---|---|
| Active Herbal tea | Active comparator | Drug: Herbal TeaOne tea bag infusion three times a day each before breakfast, lunch and dinner. |
| Placebo Tea | Placebo comparator | Drug: Placebo TeaSimilar looking tea bag infusion three times a day each before breakfast, lunch and dinner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND
- Glycosylated haemoglobin (A1C) ≥ 6.5 %.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal TeaAll 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. | Drug | Active Herbal tea |
| Placebo TeaSimilar looking inert placebo tea. | Drug | Placebo Tea |
Primary outcome
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.
1 secondary outcome
Flash Glucose Measurements
Time frame: 2 days and 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HD Ramachandra Prabhu, MBBS, MD principal investigator
Health India Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Tea in people with Type 2 Diabetes Mellitus, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjaya Chauhan, Pharm.D (09611252350, drsanjayachauhan49@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose (FPG) (time frame: 2 days and 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.