None listed
Conditions
Sponsors
Council of Scientific Industrial Research New Delhi
Indian Institute of Integrative Medicine, Jammu
Eligibility
Inclusion criteria
Inclusion criteria: Patients satisfying all the following criteria are included in the study: 1. Patients of either sex between the age group 18 to 60 years (both inclusive). 2. Patients with type 2 diabetes mellitus (with duration of diabetes at least 2 years) on sulfonylurea (SU) (half of the maximum prescribed dose) and/or Metformin (1500mg/day) for at least one month prior to enrolling the patient in the study 3. Patients with fasting blood glucose more than 126mg % and /or with post-prandial blood glucose (after a standard meal) more than 162mg. %. 4. Patients with HbA1c between 7.0-9.5 %. 5. Patients ready to abide by trial procedures and to give informed consent.
Exclusion criteria
Exclusion criteria: A.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 >9.5 %. e. Patients with ASAT and ALT levels greater than 2.5 times than 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 abuse 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 Ayurvedic/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month 8. Patient should not be receiving on any other anti-diabetic medications except Metformin and those belonging to the Sulfonylurea group. B. Pregnant or lactating females and women in child bearing age refusing to use contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures will be reduction in HbA1c levels by 0.5% as compared to basal values, reduction in blood sugar (fasting and/or post-prandial) and lipid levels by more than 25% in the group receiving PHP-Diabetes as compared to placebo at the end of three months treatment, less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups, improvement in the signs & symptom score by more than 10% in the group receiving PHP-Diabetes as compared to placebo at the end of three months treatment and total number of patients showing reduction in the blood sugar levels by more than 3/10 in the group receiving PHP-Diabetes as compared to placebo at the end of three months treatment.Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be improvement in insulin sensitivity as determined by indices of Insulin sensitivityTimepoint: | — |
Countries
India
Contacts
Public ContactDr. Shilpa Gaikwad
Professor & Head, Dept. of Clinical Pharmacology
Outcome results
None listed