What is the efficacy and safety of a polyherbal capsule (MAP_G) on selected metabolic markers in patients with type 2 diabetes mellitus and prediabetes in comparison to placebo treated groups?

Study subjects meeting inclusion and exclusion criteria attending the National Hospital, Kandy 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 (block randomization). Both intervention and control arms will be divided to three sub arms; Type II diabetes Patients with one drug, Prediabetes with one drug and Prediabetes without medication. The prediabetes patients without medication will take the herbal/placebo drug alone. Both diabetes and prediabetes patients with one drug, will take herbal/placebo drug and their usual drug.

Interventional product: freeze dried powder of the aqueous refluxed extract of polyherbal mixture 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 three times a day for a total of 3 months.

Placebo arm: participants will receive matching placebo capsules to be taken (1 capsule) three times 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. Willing to comply with all study procedures and be available for the duration of the study
2. Adult males and females between 20 and 65 years. Able to communicate effectively with the study personnel.
3. Prediabetes or Type 2 diabetes.
4. Patients with fasting plasma glucose concentration of FPG 100–125 mg/dL (5.6–6.9 mmol/L)/ 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L)/ HbA1C 5.7–6.4% will be enrolled for the present study for sub-arm 1 and 2 (prediabetes). Sub-Arm 3 (Type 2 diabetes) will be patients with FBS>= 126, 2 hour OGTT >=200 and HbA1c >=6.5) on one drug.
5. Normal neutrophil level; between 1,500 and 8,000 neutrophils per microliter
6. Normal serum creatinine level; 0.7 to 1.3 mg/dL (61.9 to 114.9 µmol/L) for men and 0.6 to 1.1 mg/dL (53 to 97.2 µmol/L) for women
7. Normal number of WBCs in the blood; 4,500 to 11,000 WBCs per microliter

1. Subjects who has exclusionary laboratory values as listed in the following table Parameter Study Limit for Exclusion Creatinine Male: >=1.4 mg/dL (>=124 mol/L) Female: >=1.3 mg/dL (>=115 mol/L) Estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 ALT >2.5 times ULN AST >2.5 times ULN Hemoglobin Below Normal Range
2. Individuals with malignancies or those receiving corticosteroid or other hormonal-modulating therapies.
3. Hypersensitivity or idiosyncratic reaction to herbal products contained in the capsule.
4. Subjects who are scheduled to undergo hospitalization for surgery during the study period
5. Use of any recreational drugs or a history of drug addiction.
6. Participation in a clinical study of any investigational product one month prior to the first visit or during the study.