type 2 diabetes mellitus
Conditions
Interventions
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 ar
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 diabete
Sponsors
National Research Council, Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the polyherbal capsule MAP-G on reducing blood glucose: as determined by serum concentrations of fasting glucose, fructosamine, Serum insulin, HbA1c, C- Peptide [At baseline (FBS,Serum insulin, HbA1c, fructoseamine,C- Peptide), end of the second week, fourth week, eighth week, tenth week (FBS), and twelfth week (HbA1 C, Serum insulin, C- Peptide, FBG, Fructosamine tests) from the commencement of intervention ] Toxicity/adverse effects of the drug: as determined by serum concentration of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, full blood count (FBC) [At baseline (ALT, AST, ALP Urine albumin: creatinine ratio & serum creatinine), end of the second week, fourth week, eighth week, tenth week (ALT,FBC), twelfth week (ALT, AST Urine albumin: creatinine ratio & serum creatinine) from the commencement of intervention.] Toxicity/adverse effects of the drug: as determined by serum concentration of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, full blood count (FBC) [At baseline (ALT, AST, ALP Urine albumin: creatinine ratio & serum creatinine), end of the second week, fourth week, eighth week, tenth week (ALT,FBC), twelfth week (ALT, AST Urine albumin: creatinine ratio & serum creatinine) from the commencement of intervention.] Toxicity/adverse effects of the drug: as determined by serum concentration of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, full blood count (FBC) [At baseline (ALT, AST, ALP Urine albumin: creatinine ratio & serum creatinine), end of the second week, fourth week, eighth week, tenth week (ALT,FBC), twelfth week (ALT, AST Urine albumin: creatinine ratio & serum creatinine) from the commencement of intervention.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of the polyherbal capsule of MAP-G on selected glycaemic markers (Hexokinase, 6-Phosphofructokinase (PFK)) and antioxidant markers (Glutathione peroxidase 1 (GPX1), Catalase) [At baseline, and the end of the twelfth week from the commencement of intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactJMSJ Manike
Senior lecturer
Outcome results
None listed