Type 2 diabetes mellitus
Conditions
Interventions
Study subjects meeting inclusion and exclusion criteria attending the university medical clinics, Teaching Hospital, Karapitiya will be recruited for the study. Participants will be randomly allocated
Sponsors
National Research Council, Sri Lanka
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the herbal capsule of C. grandis on reducing blood glucose: as determined by serum concentrations of fasting glucose, fructosamine, insulin, HbA1c [At baseline, end of the second week, fourth week, eighth week, twelfth week (insulin, HbA1c at once) from the commencement of intervention] Toxicity/adverse effects of the drug: as determined by serum concentration of gamma glutamyl transferase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, full blood count (FBC) [ At baseline, end of the second week, fourth week, eighth week, twelfth week from the commencement of intervention ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of the herbal capsule of C. grandis on oxidative stress: as determined by malonaldehyde (MDA), Glutathione peroxidase(GPx), Glutathione reductase (GR), Glutathione S-transferase, Reduced glutathione (GSH), [ At baseline, and the end of the twelfth week from the commencement of intervention ] Effect of the herbal capsule of C. grandis on inflammation: as determined by high sensitivity C-reactive protein(hsCRP), interleukin-6(IL-6), tumor necrosis factor-alpha (TNF- a) [ At baseline, and the end of twelfth week from the commencement of intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactDr A.P. Attanayake
Senior Lecturer in Biochemistry
Outcome results
None listed