Clinical trial NCT03143803: Control of Blood Glucose Fluctuation With Usage of Polyherbal
Official title: Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2017-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean amplitude glycemic excursion
timeFrame: 14 days
Secondary outcomes:
measure: Mean estimated glycated hemoglobin
timeFrame: 14 days
measure: Number of hypoglycemia episodes
timeFrame: 14 days
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical Centre
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Alben Sigamani
role: PRINCIPAL_INVESTIGATOR
References: