Health Condition 1: null- Type-II Diabetese Mellitus
Conditions
Interventions
Intervention1: NISHAKATAKADI
KASHAYA,YASHADA BHASMA: Group-1: NISHAKATAKADI
KASHAYA Dose â?? 15ml twice
daily(to be diluted with 45ml of
Water)
Dosage form â??
Kashaya(Liquid),Route of
Administration â?? oral
Time of
Administration-Twice a day
before food
Packing form- Bottle containing
450 ml Kashaya
Duration of
therapy-84 Days Group-2:
YASHADA BHASMA
Dose-125mg (1 Capsule) thrice
daily
Dosage form-
Capsule
Route of
Administration-oral
Time of
Administration-Thrice a day
before food
Anupana-Luke
warm Water
Packing
form-Plastic jar containing 45
Capsules
Duration of
therapy-84 days. Group-3:both
NISHAKATAKADI KASHAYA &
YASHADA BHASMA
Control Intervention1: NIL: NIL
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed to be Type II Diabetics by either HbA1c >6.5%. or BS-F >126 mg% of BS-PP >200 mg% / Diabetics who are on lifestyle modification & /or on Tab.Metformin upto 2gm/ day. 2. Willing to participate in clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc. 2. Patients suffering from Type-I / brittle diabetes mellitus. 3. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 4. Patient with poorly controlled Hypertension ( >140 / 90 mm Hg). 5. Patient with poorly controlled Gycemic status(HbA1c >8 %). 6. Symptomatic patient with clinical evidence of Heart failure. 7. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 8. Pregnant / Lactating women. 9. Patient on steroids, oral contraceptive pills or estrogen replacement therapy. 10. Alcoholics and/or drug abusers. 11. Patients with evidence of malignancy. 12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Blood Sugar Fasting(10-12 hours after dinner)Timepoint: Change in Blood Sugar Fasting(10-12 hours after dinner) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Blood sugar Post -Prandial. (100-120 minutes after breakfast)Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up on 98th Day;Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At Baseline and 84th day;Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)Timepoint: At Baseline-84th day and at the end of follow up on 98th Day;Change in the SF-36-Health Survey ScoreTimepoint: At Baseline,at 84th day and at the end of follow up on 98th Day | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed