Diabetes Mellitus
Conditions
Brief 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.
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.
Interventions
A unique combination of 3 herbs that lower blood sugars
DRUGPlacebo
Similar looking inactive powder
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 1. Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND 2. 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.
Exclusion criteria
Any one of the following 1. Patients on Insulin therapy. 2. Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes. 3. Women in child bearing age unable to practice any form of contraception 4. Patients with diagnosis of Anemia (Hb\<11 g/dl in Female and \<13 g/dl in Male) 5. Impaired renal function; estimated estimated glomerular filtration rate \<60mls/min/1.73m2. 6. Known history of any chronic illness taking regular pharmacological agents. 7. 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 8. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy 9. Current or former employees of organic India or any potential conflict of interest in participation 10. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. 11. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean amplitude glycemic excursion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean estimated glycated hemoglobin | 14 days | Mean estimated glycated hemoglobin difference between test and placebo control group |
| Number of hypoglycemia episodes | 14 days | Number of hypoglycemia episodes and duration of hypoglycemia in treatment group |
Countries
India
Outcome results
None listed