What is the effect of a herbal capsule of Coccinia grandis on selected metabolic markers in patients with newly diagnosed type 2 diabetes mellitus?

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 to either to the intervention arm (herbal drug) or the control arm (placebo) using random number tables.

Interventional product: freeze dried powder of the aqueous refluxed extract of C. grandis in oral gelatin capsules.

Placebo: corn starch in identical oral gelatin capsules

Intervention arm: participants will receive 500mg of the herbal capsule (1 capsule) to be taken twice a day for a total of 3 months.

Placebo arm: participants will receive matching placebo capsules to be taken (1 capsule) twice a day for a total of 3 months.

All participants will receive standard management, including non-pharmacological interventions in accordance with the guidelines of the Sri Lanka College of Endocrinologists and the American Diabetes Association. Patients will be strictly advised to refrain from taking additional herbal supplementation/ neutraceutical products/home- made recipes/ herbal decoctions for the stipulated intervention period.

Study participants and data collectors/analysts will be blinded to the intervention

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

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