Diabetes MellitusNCT03143803
Control of Blood Glucose Fluctuation With Usage of Polyherbal
A study testing Polyherbal capsule coccinia, bougainvillea, catharanthus in people with Diabetes Mellitus, run by Composite Interceptive Med Science at 1 site in India.
Trial summary
The aim of the study is to get insight into control of glycemic variability with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Polyherbal capsule coccinia, bougainvillea, catharanthus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 5 May 2017to 30 Aug 2017
- 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
- Adult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
- Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
- Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months.
Who cannot join
- Any one of the following
- Patients on Insulin therapy.
- 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 Anemia (Hb<11 g/dl in Female and <13 g/dl in Male)
- Impaired renal function; estimated estimated glomerular filtration rate <60mls/min/1.73m2.
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- Known history of any chronic illness taking regular pharmacological agents.
- Blood pressure fluctuations exceeding 20 mm of Hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks
- Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
- Current or former employees of organic India or any potential conflict of interest in participation
- Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations
The aim of the study is to get insight into control of glycemic variability with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.
Read the detailed description
The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.
- Conditions
- Diabetes Mellitus
- Being tested
- Polyherbal capsule coccinia, bougainvillea, catharanthus, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyherbal capsule coccinia, bougainvillea, catharanthusDrug
Also called Sugar Balance (SB)
A unique combination of 3 herbs that lower blood sugars
PlaceboDrug
Similar looking inactive powder
| Study group | Role | What they receive |
|---|---|---|
| Polyherbal | Active comparator | Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea. Receives: Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus |
| Placebo | Placebo comparator | Placebo will contain an inert substance Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amplitude glycemic excursion
To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days
Measured: 14 days
Secondary outcomes (2)
Mean estimated glycated hemoglobin
Mean estimated glycated hemoglobin difference between test and placebo control group
Measured: 14 days
Number of hypoglycemia episodes
Number of hypoglycemia episodes and duration of hypoglycemia in treatment group
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start5 May 2017
- Primary completion14 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alben Sigamani, Principal investigator, Narayana Hrudayalaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143803
- Sponsor's protocol ID
- OI-005-2017
- Status last verified
- Sep 2017
- First submitted
- 2 May 2017
- Last updated
- 5 Sep 2017
- 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 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations
- ClinicalTrials.gov ID
- NCT03143803
- Acronym / sponsor ID
- OI-005-2017
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 8 May 2017 (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.
The aim of the study is to get insight into control of glycemic variability with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.
Detailed description
The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyherbal | Active comparator | Drug: Polyherbal capsule coccinia, bougainvillea, catharanthusPolyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will contain an inert substance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
- Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
- Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months.
Key exclusion criteria (12 listed)
- Any one of the following
- Patients on Insulin therapy.
- 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 Anemia (Hb<11 g/dl in Female and <13 g/dl in Male)
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 |
|---|---|---|
| Polyherbal capsule coccinia, bougainvillea, catharanthusAlso: Sugar Balance (SB)A unique combination of 3 herbs that lower blood sugars | Drug | Polyherbal |
| PlaceboSimilar looking inactive powder | Drug | Placebo |
Primary outcome
Mean amplitude glycemic excursion
Time frame: 14 days
To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days
2 secondary outcomes
Mean estimated glycated hemoglobin
Time frame: 14 days
Number of hypoglycemia episodes
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- 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.
Alben Sigamani principal investigator
Narayana Hrudayalaya 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 Polyherbal capsule coccinia, bougainvillea, catharanthus in people with 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 5 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amplitude glycemic excursion (time frame: 14 days). 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 5 Sep 2017.