To Study the effect of Ayurvedic drug- Prmehagajakesari Rasa in the treatment of Diabetes

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects already diagnosed with Type II Diabetes mellitus with secondary failure to oral hypoglycemic drugs.

2.Subjects having HbA1c value between 6 - 9 % at screening.

3.Subjects having Fasting Plasma Glucose 125-250 mg/dl and Post prandial Plasma Glucose not more than 300mg/dl at screening.

4.Subjects of either sex in the age group of 18 to 70 years, both inclusive.

5.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

Exclusion Criteria

1.Subjects of Type I Diabetes Mellitus

2.Known cases of Severe/ Chronic hepatic or renal disease.

3.Subjects having any active malignancy.

4.Subjects giving history of significant cardiovascular event <12 weeks prior to screening.

5.Subjects having known major complications of Diabetes like Ketoacidosis, nephropathy, Neuropathy, Retinopathy and Diabetic wounds.

6.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C or HIV.

7.Subjects having active metabolic or gastrointestinal disease that may interfere with nutrient absorption, metabolism, or excretion, excluding Diabetes.

8.Pregnant and Lactating female Subjects

9.Known hypersensitivity to any of the ingredients used in study drug.

10.Subjects using any other investigational drug within 1 month prior to recruitment or currently participating in any other clinical trial.

11.Any other condition due to which subjects are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assessment of changes in HbA1c(Glycosylated hemoglobin) levels over 3 months (90days) <br/ ><br>2.Monthly assessment of changes in fasting and post prandial plasma glucose levelsTimepoint: at the end of 90 days

Secondary Outcome Measures

Name	Time	Method
1.Monthly Assessment of changes in like Body weight, BMI, Waist Circumference, Hip circum., Waist/Hip ratio.2.Monthly ass. of QOL on WHO QOL questionnaire 3.Monthly Ass.of changes in the clinical symptoms of Type II Diabetes mellitus <br/ ><br>4.Monthly ass. of level of energy, level of stamina and physical strength 5.Monthly ass. of level of Stress using VAS Scale. 6.Ass. on CGI-I Scale. 7.Global ass. of overall safety of intervention as per the Physician & SubjectTimepoint: at the end of 90 days