Health Condition 1: null- Patients with Type II diabetes mellitus.
Conditions
Interventions
Intervention1: Terminalia chebula: Terminalia chebula 500mg twice daily for 12 weeks.
Control Intervention1: Placebo: Placebo twice daily for 12 weeks
Sponsors
No funding
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to give written informed consent 2. Patients should be on stable dose of anti-diabetic medication (taking Metformin alone in dose between 1000-2500mg per day or in combination with glimiperide maximum 6 mg per day) as prescribed by the physician over past 8 weeks prior to screening visit. 3. Having HbA1c between 6.5-8%. 4. Mean decrease in RI <=6% on salbutamol challenge test at baseline.
Exclusion criteria
Exclusion criteria: 1.Uncooperative Patients 2. H/O drug or alcohol abuse, not willing to abstain from drinking during the study period 3. Pregnant and nursing women, women in child bearing age not willing to comply with double contraceptive method. 4. Any clinically significant abnormality identified on physical examination or laboratory tests 5. Patients having acute coronary syndrome (MI or Unstable Angina) or new or worsening symptoms of coronary heart disease, Coronary artery Intervention (CABG or PTCA), Stroke or transient ischemic neurological disorder. 6. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal. 7. Impaired renal function indicated by serum creatinine >1.5 mg/dl. 8. History of malignancy 9. Concomitant use of any other antioxidants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measure was a change in endothelial dysfunction assessed by change in reflection index at 12 weeks in both the treatment groups compared to baseline.Timepoint: at baseline and post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Secondary efficacy measures includes change in markers of oxidative stress and change in lipid profile after 12 weeks of treatment in both the groups. 2. Change in pain threshold and pain tolerance time at post treatment.Timepoint: at baseline and post treatment. | — |
Countries
India
Contacts
Public ContactDrP Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed