Health Condition 1: null- Diabetes Mellitus
Conditions
Interventions
Intervention1: Poly herbal capsule: Sugar balance® (SB) contains 3 whole herbs, Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle or sadabahar.
Control Intervention1: Placebo Inert
Sponsors
Organic India
Eligibility
Inclusion 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 NABL certified and standardized within last 3 months.
Exclusion criteria
Exclusion criteria: Any one of the following 1.Patients on Insulin therapy. 2.Any history suggestive of micro vascular or macro vascular disease â?? 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 5.Impaired renal function; eGFR 6.Known history of any chronic illness taking regular pharmacological agents. 7.Blood pressure fluctuations exceeding 20mmHg 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 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 |
|---|---|
| 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 10 daysTimepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean estimated glycated hemoglobin differenceTimepoint: 10 days;Number of hypoglycemia episodesTimepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr Sindhu N
Outcome results
None listed