A clinical trial to check efficacy of vanga shilajatu in madhumeha (type 2 diabetes mellitus)

Phase 2

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Lead Sponsor: Shri krishna Govt Ayurvedic college and Hospital, kurukshetra Haryana 136118

Recruitment & Eligibility

Inclusion Criteria

1.Patients willing for clinical trials and ready to give written consent.

2.Patients with age between 25-60yrs of either sex.

3.Patients possessing signs and symptoms of Madhumeha (Diabetes Mellitus).

4.Diagnosed & confirmed cases of Madhumeha on the basis of Diagnostic criteria for diabetes.

Exclusion Criteria

1. Patients not willing for the clinical trial.

2. Patient not fulfilling the inclusion criteria.

3. Patients below the age of 25 years and above the age of 60 years

4. Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl

5. Post Prandial Blood Sugar Level <200 mg/dl and >300 mg/dl

6. HbA1c <6.5% and >7%.

4. Patients of Insulin dependent Diabetes Mellitus (IDDM)

5. Patients with diabetic complications such as impaired renal functions.

6. Patients suffering from Secondary Diabetes.

7. Gestational diabetes.

8. Pregnant ladies and lactating mothers.

Primary Outcome Measures

Name	Time	Method
Changes in symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic) will be analyzed on each 7th days during treatment and post treatment again changes in all symptoms and lab test (FBS, PPBS, KFT, SGOT, SGPT, Urine routine and microscopic, Lipid Profile, CBC, HbA1c) will be examined to evaluate the effect of treatment on particular patient.Timepoint: Treatment Duration 28 days <br/ ><br>Follow up on 7th, 14th,21st and 28th day.

Secondary Outcome Measures

Name	Time	Method
1.To study the effect of drug on clinical parameter & biochemical finding associated with Madhumeha Madhumeha (Diabetes Mellitus) <br/ ><br>2.To advise preventive measures to check the occurrence of disease individuals and masses. <br/ ><br>3.To standardize an ayurvedic line of treatment both drug and dose which may have an effective role in management of patients of Madhumeha. <br/ ><br>4.To explain the Madhumeha on the basis of critical review in classic text of Ayurveda and with the help of modern literature. <br/ ><br>5.To provide cheap, safe and effective treatment from Ayurveda to Madhumeha patients. <br/ ><br>Timepoint: 2 years