Health Condition 1: null- Type 2 Diabetes mellitus
Conditions
Interventions
Intervention1: Chyawanprakash: Bilva, Agnimanth, Shyonaka, Patala, Gambhari, Shalparni, Prishnaparni, Brihati, Kantakari, Gokshur, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha, Pushkara, H
Sponsors
Dabur Research Development Centre DRDC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / polydrug oral anti-diabetic therapy. 2.Subjects having HbA1c value below 8% at screening. 3.Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening. 4.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal. 5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects on Insulin therapy. 2.Subjects suffering from Type I DM or type of Diabetes mellitus other than Type II. 3.Subjects having known hepatic or renal disease. 4.Subjects having an active malignancy. 5.Subjects giving history of significant cardiovascular event 6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 7.Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 8.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 9.Subjects using any other investigational drug within 1 month prior to recruitment 10.Known hypersensitivity to any of the ingredients used in study drug 11.Pregnant and Lactating females. 12.Subjects participating in another Clinical trial 13.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values. 2.Post-treatment Physician global assessment of overall safety of Dabur Chyawanprakash Timepoint: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Monthly assessment of changes in fasting & postprandial plasma glucose levels 2.Assessment of Adverse Drug Reaction 3.Monthly assessment of clinically significant abnormal laboratory parameters 4.Assessment of clinical symptoms of Diabetes 5.Assessment of changes in pre and post treatment of serum insulin (fasting state) levels 6.Monthly assessment of changes in micro-albuminurea 7.Monthly assessment of changes in dose of OHAs 8.Monthly assessment of Quality of Life (On WHO Scale) Timepoint: 0, 1, 2, 3 months | — |
Countries
India
Contacts
Public ContactBhavana Zalavadiya
Target Institute of Medical Education and Research
Outcome results
None listed