SLCTR/2018/012RecruitingPhase 2
Effect of a standardized herbal capsule of Coccinia grandis (L.) Voigt on selected metabolic parameters in patients with type 2 diabetes mellitus: A Randomized Controlled Trial
ational Research Council, Sri Lanka0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Adults of either sex aged between 30 - 60 years
- •2. Newly diagnosed with type 2 diabetes mellitus
- •3. Fasting plasma glucose concentration of 126 mg/dL (7.0 mmol/L)-160 mg/dL (8.9 mmol/L) and/or the percentage of glycated haemoglobin of 6.3 – 7.5%
- •4. Able to communicate effectively with the study personnel
- •5. Able to be informed of the nature of the study and willing to give written informed consent
Exclusion Criteria
- •1. Subjects who are on any type of antihyperlipidaemic or antihypertensive therapy which can influence glycaemic control (statins, thiazides respectively)
- •2. History of hypersensitivity or idiosyncratic reaction to any drugs or herbal products
- •3. Any disease or condition which may compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
- •4. History of allergic conditions
- •5. History or presence of gastric ulcer or duodenal ulcer
- •6. History of autoimmune disorders
- •7. History of psychiatric disorders
- •8. Intake of herbal products/ supplements/ home decoctions within 14 days prior to the commencement of the study
- •9. Intake of any long term medication (steroids, thyroxin, nutritional supplements, weight reducing agents etc.) which has effects on hyperglycaemia, dyslipidaemia, hypertension etc
- •10. Scheduled to undergo hospitalization for surgery during the study period
- •11. Presence of clinically significant abnormal laboratory results in liver function tests (ALT > x3 times of the upper limit) and renal function tests (eGFR< 90 mL/min/1.72m2) during screening
- •12. Pregnancy or breastfeeding
- •13. Use of any recreational drugs or a history of drug addiction
- •14. Participation in a clinical study of any investigational product one month prior to the first visit or during the study
- •15. Severe hyperglycaemia (above 300 mg/dL) or infection at the time of diagnosis of T2DM
- •16. Any other medical condition considered unsuitable for enrolment by a consultant physician
Investigators
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