A clinical trial to study the effects of Phalatrikadi kwath and Madhugrit in patients with Type 2 Diabetes Mellitus.

Phase 2

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

Recruitment & Eligibility

Inclusion Criteria

1.Participants will be selected irrespective of gender and socio-economic status.

2.Patients aged between 30 – 65 years.

3.Participants fulfilling the signs and symptoms of Madhumeha.

a. Prabhutmutrata (Polyuria)

b. Kar-pada daha (Burning sensation in hands and feet)

c. Kantha taalusosha (polydipsia)

d. Availa mutrata (Turbid urine)

e. Angasaad (Fatigue)

f. Mukha Madhuryasyata (Sweet taste of mouth)

g. Daurgandhaya (Foul smell)

h. Blood glucose level

i. Fasting Blood glucose from 126mg/dl to 200 mg/dl

j. Post-Prandial Blood glucose from 200 mg/dl to 300 mg/dl

k. HBA1C > 6%

Exclusion Criteria

1. Patients with Type I Diabetes (Juvenile Diabetes)

2. Patients who are taking insulin.

3. Women with Gestational Diabetes.

4. Diabetes Mellitus with Hypertension, other endocrinological diseases and any other systemic disease.

5. Diabetes Mellitus with complications such as Retinopathy, Nephropathy and Diabetic foot

6. Pregnancy and lactating women.

Primary Outcome Measures

Name	Time	Method
Subjective parameters <br/ ><br>1.Prabhoot-mutrata (Polyuria - frequency of urination) <br/ ><br>2.Kanth taalu shosh (Polydipsia – the feeling of thirst) <br/ ><br>3.Angsaad (Fatigue) <br/ ><br>4.Avilmutrata (turbid urine) <br/ ><br>5.Mukha – madhuryata (sweet taste of mouth) <br/ ><br>6.Daurgandhaya (foul smell) <br/ ><br>7.Karpada-daha (burning sensation in hand and feet) <br/ ><br> <br/ ><br>Objective parameters <br/ ><br>The objective assessment will be done on the basis of changes in the following <br/ ><br>•Fasting Blood glucose <br/ ><br>•Post-Prandial Blood glucose <br/ ><br>•Lipid Profile <br/ ><br>•Urine test for glucose <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 0 days, 30 days, 60 days, 90 days <br/ ><br>HbA1c – <br/ ><br>Time point - 0 days and 90 days <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Objective parameters <br/ ><br>The objective assessment will be done on the basis of changes in the following <br/ ><br>1. Fasting Blood glucose <br/ ><br>2. Post-Prandial Blood glucose <br/ ><br>3. Lipid Profile <br/ ><br>4. Urine test for glucose <br/ ><br>Timepoint: 0 days, 30 days, 60 days, 90 days <br/ ><br> <br/ ><br>HbA1c – <br/ ><br>Time point - 0 days & 90 days