Control of Glycemic Variability using a polyherbal: A randomized placebo controlled study of whole herb formulations.

Organic India0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 <11 g/dl in Female and <13 g/dl in Male)
•5.Impaired renal function; eGFR <60mls/min/1.73m2.
•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.

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