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se of Vidangadi Loha as compared to Metformin in Prediabetes

Phase 2
Conditions
Health Condition 1: R739- Hyperglycemia, unspecified
Registration Number
CTRI/2021/10/037124
Lead Sponsor
Self Dr Sonal Abhijeet Shah
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Newly diagnosed cases of hyperglycaemia with lakshanas of Prameha like Prabhut mootrata, Trishna, Kshudhadhikya, Dourbalya, Dantadinammaladhyatvam, Atinidra with Madhumeha Assessment Tool (As mentioned in case paper) Score more than 10 and patients those having Blood Sugar level fasting 100 to 125, Postprandial Blood sugar level more than 140 and less than 200 and HbA1C 5.7 to 6.4 % will be selected for the study.{According to Rashtriya Madhumeha Abhiyan , Ministry of Ayush, Government of India} According to American Diabetes Association Criteria.

Exclusion Criteria

i)Type 2 Diabetes Patients, Juvenile Diabetes, Pregnancy induced Diabetes Mellitus patients will be excluded from study.

ii)Patients receiving insulin and those with increased blood sugar level and showing normal or poor control in glycosylated hemoglobin.

iii)Patients Suffering from Diabetic Complications like Neuropathy, Retinopathy, Nephropathy, keto acidosis, Gangrene will be excluded from study.

iv)Immune deficiency patient, chronic major illness will be also excluded from study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To evaluate the efficacy of Vidgandi Loha in the management of Prediabetes based on serum levels of fasting and postprandial blood glucoseTimepoint: 90 days with Follow Up on 30th,60th and 90th day
Secondary Outcome Measures
NameTimeMethod
1.To study the efficacy of Vidangadi loha in the management of Prediabetes based on serum levels of fasting and postprandial blood glucose. <br/ ><br>2.To compare the effect of Vidangadi Loha with standard Metformin in the management of Prameha with special reference to Prediabetes. <br/ ><br>3.To evaluate the efficacy of Vidangadi loha tablets in the management of Prediabetes compared with Metformin tablet based on Glycosylated hemoglobin, lipid profile and clinical symptoms. <br/ ><br>4.To review the modern literature on Prediabetes in detail. <br/ ><br>Timepoint: 90 days with Follow Up on 30th,60th and 90th day
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