effect of Tukhm-e-Hulba and Gilo in Type 2 Diabetes Mellitus

Not Applicable

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

Recruitment & Eligibility

Inclusion Criteria

Any one of these:

Fasting blood sugar (FBS): 126mg/dl to 180mg/dl (or)

Post Prandial blood sugar (PPBS): 200mg/dl to 250mg/dl (or)

Glycated haemoglobin (HbA1C): 6.0% to 7.5%

Patient willing to sign the written informed consent.

Newly diagnosed patient of Type 2 Diabetes mellitus.

Known case of Diabetes mellitus not taking any traditional or conventional treatment.

Urine for microalbuminuria: A1 and A2

Patient having BMI more than or equal to 18.5

Exclusion Criteria

Patients below 30 years and above 60 years of age.

Presence of any evidence suggestive of microvascular and macrovascular complications.

Patients of Malnutrition related Diabetes mellitus (MRDM).

Any co-morbid condition.

Pregnant and lactating women.

Patient who fail to give consent.

Patient who fail to follow up.

Mentally retarded person.

Patient having uncontrolled hypertension.

Primary Outcome Measures

Name	Time	Method
Improvement in: <br/ ><br>Blood sugar fasting <br/ ><br>Blood sugar PP <br/ ><br>No improvement <br/ ><br>less than 10 mg/dl <br/ ><br>Mild improvement <br/ ><br>10-20 mg/dl <br/ ><br>Moderate improvement <br/ ><br>20-30 mg/dl <br/ ><br>Significant improvement <br/ ><br>more than 30 mg/dl <br/ ><br>Improvement in HbA1C levels <br/ ><br>No improvement <br/ ><br>less than 0.2 mg/dl <br/ ><br>Mild improvement <br/ ><br>0.2-0.4 mg/dl <br/ ><br>Moderate improvement <br/ ><br>0.4-0.6 mg/dl <br/ ><br>Significant improvement <br/ ><br>more than 0.6 mg/dlTimepoint: Blood sugar fasting: Baseline, 15th, 30th, 60th, 90th day <br/ ><br>Blood sugar PP : Baseline, 15th, 30th, 60th, 90th day <br/ ><br>HbA1C levels : Baseline, 90th day <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Improvement in Urine for microalbuminuria <br/ ><br>A1 Normal to mildly increased <br/ ><br>less than 30 <br/ ><br>A2 Moderately increased <br/ ><br>30 -300 <br/ ><br>A3 Severely increased <br/ ><br>More than 300 <br/ ><br>Improvement in subjective parameters (Polyuria, Polydipsia, Polyphagia, Nocturia, Increased fatigue) <br/ ><br>Reduction in BMI to normal range <br/ ><br>Reduction of waist circumference to normal rangeTimepoint: Subjective parameters: 0th, 15th , 30th , 45th , 60th , 90th day <br/ ><br>Urine (routine & microscopic) :at beginning and end of study <br/ ><br>Urine for microalbuminuria :at beginning and end of study <br/ ><br>BMI :at beginning and end of study <br/ ><br>Waist circumference :at beginning and end of study