Effect of herbal drugs on blood sugar level
- Conditions
- Health Condition 1: null- Diabetes Mellitus
- Registration Number
- CTRI/2017/05/008535
- Lead Sponsor
- Organic India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean estimated glycated hemoglobin differenceTimepoint: 10 days;Number of hypoglycemia episodesTimepoint: 10 days