Health Condition 1: null- Type 2 Diabetes
Conditions
Interventions
Intervention1: SNEC30 (Curcuma Longa): Each 900 mg capsule contains:-
SNEC30 (Curcuma Longa) Eq. to Curcuminoids â?¦. 30 mg
Two Capsule twice daily orally for 12 weeks
Control Intervention1: conventio
Sponsors
Arbro Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject or his legally accepted representative is willing to give informed consent 2 Patients of either sex between the age group 18 to 65 years (both inclusive) 3 Suffering from diabetes type 2 ( between 1 to 10 years) 4 Patients with diabetes who administer oral hypoglycemic agents 5 Patients with HbA1c between 7.0-9.5 %.
Exclusion criteria
Exclusion criteria: 1 Patients suffering from any of the following conditions will be excluded from the study: a Type 1 diabetes mellitus b Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%) c Patients with fasting serum cholesterol >260mg% and serum Triglycerides >300 mg%. d Patients with HbA1c more than 9.5 %. e Patients with AST and ALT levels greater than 2 5 times the upper normal limits f Severe renal, hepatic or respiratory disorder. g Patients with psychiatric disorder. h Patients with haematological disorders I History of smoking (more than 10 cigarettes/day) or alcohol intake > 20 gm/day. j Complications of diabetes such as; Proliferative type retinopathy Nephropathy with laboratory values greater than 1.5 times the upper normal limits Presence of ketone bodies in urine analysis Ischemic heart disease with any cardiac event in last 6 months Fasting serum cholesterol >260mg. % and serum Triglycerides >300 mg%. 2 Patients with BMI >35 kg/m2 3 Patients who are likely to undergo surgery during the study period. 4 Patients who have participated in any investigational study in the last 4 weeks. 5 Patients having known hypersensitivity to the study drugs. 6 Patients with any severe infection 7 Patients with a history of intake of ANY Ayurveda/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month 9 Pregnant or lactating females and women in child bearing age refusing to use contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary outcome measures will be reduction in HbA1c levels by 0.5% as compared to basal values. Timepoint: HbA1c levels will be checked at the time of screening and week 12 at the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in adverse event for both the groupsTimepoint: At the time of screening vs end of treatment (week 12) | — |
Countries
India
Contacts
Public ContactDr Navneet Kumar Gupta
KGMU Lucknow
Outcome results
None listed