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A clinical trial to study the effect of novel ayurvedic choorna in patients with Type 2 Diabetes mellitus

Phase 2
Conditions
Health Condition 1: - Health Condition 2: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2020/10/028201
Lead Sponsor
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Subjects of all gender and age group between 30-60 years will be included.

Subjects with FBS greater than or equal to 126mg/dl and or PPBS greater than or equal to 200mg/dl will be included.

Subjects with HbA1c greater than or equal to 6.5%

Diagnosed cases of Type2 Diabetes Mellitus.

Subjects with and without signs and symptoms of Prameha vis-a-vis Type2 Diabetes Mellitus will be included.

Exclusion Criteria

Subjects with history of Diabetes Mellitus associated with complications like diabetic nephropathy, retinopathy, neuropathy, infectious wounds and gangrene will be excluded.

Patients with known systemic disorders like; cardiac illness, renal pathologies, other endocrinal diseases, uncontrolled hypertension, infectious conditions and debilitating illness which interfere with intervention will be excluded.

Patients of Type 2 Diabetes Mellitus who are on OHA and Insulin treatment will be excluded.

Subjects on any other medications, drug and alcohol abuse, Steroids and Estrogen replacement therapy will be excluded.

Pregnant and the lactating women will be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting Plasma Glucose Level <br/ ><br>Two-hour Plasma Glucose Level <br/ ><br>HbA1c <br/ ><br> <br/ ><br>Timepoint: 3 month
Secondary Outcome Measures
NameTimeMethod
Clinical symptoms of Diabetes Mellitus. <br/ ><br>WHO-QOL. <br/ ><br>Timepoint: 3 month
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