Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: PB-DM-04: Each Capsule contains:
Methi: 110 mg
Amla: 90 mg
Grape: 80 mg
Curcuma: 70 mg
Dosage: 2 capsules per day (one in the morning and one in the evening before meals) together wit
Sponsors
Plantachem GbR
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Diagnosed with Non insulin dependent diabetes mellitus (NIDDM) type 2, under treatment since at least 1 year • Uncontrolled diabetes type 2 • On a stable dose of metformin and/or sulfonylurea since at least 6 months before recruitment without showing any improvement • Fasting blood sugar >= 145 mg/dl but = 200 mg/dl but • HbA1C >= 7.5 % but • Patients who have been following a steady lifestyle (in terms of diet and exercise for the last 3 months) and are willing to continue the same without any changes during the study period
Exclusion criteria
Exclusion criteria: • On herbal product(s) for any condition • On any other OHA besides metformin and sulfonylurea • On insulin • Taking hypolipidemic drugs • On any drug (besides that prescribed for glycaemic control) that is known to affect blood sugar levels • Hepatic impairment • Presence of major systemic disorders • Known cases of renal impairment or cardiac disorders • Women who are pregnant / lactating/ unwilling to adopt suitable methods of contraception during the study period and for up to 3 months after study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - FBS - PPBS - HbA1c - Lipid Profile - BMI Timepoint: FBS - Day -5, Day 21, Day 42, Day 63 and Day 84 PPBS - Day -5, Day 42 and Day 84 HbA1c - Day -5, Day 42 and Day 84 Lipid Profile - Day -5, Day 42 and Day 84 BMI - Day 0, Day 21, Day 42, Day 63 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactSeema Damakale
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed