Efficacy of Trivanga Bhasma with Nisha Aamalaki churna in Diabetes Mellitus

Phase 2

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

Registration Number: CTRI/2024/05/067627

Lead Sponsor: Institute Of Teaching and Research in Ayurveda, Jamnagar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Both the sexes having age between 30 to 60 years.

2)Diagnosed case of Insulin Resistant Type II Diabetes.

3)Patients having raised BSL or HbA1C, with or without among chief complaints of Madhumeha (Prabhuta- Avilamutrata, Pipasadhikya, Kshudhadhikya etc.)

4)Known patient of Type II Diabetes and also the preliminarily diagnosed patients on the basis of signs and symptoms of the disease are confirmed by FBS and PPBS.

5)Patients having Fasting blood sugar level =126 mg/dl and =200 mg/dl and or PPBS level =200 mg/dl and =350 mg/dl.xxiii

6)Patients on conventional (Allopathic) oral hypoglycemic agents with and without medications for management of diabetes unchanged(antidiabetic management protocol) over period of last 3 months.

Exclusion Criteria

1)Age more than 60 and below 30 years.

2)All patients of diabetes mellitus receiving insulin.

3)Patients having Fasting blood sugar level less than 126 mg/dl and more than 200 mg/dl and or PPBS level less than 200 mg/dl and more than 350 mg/dl.

4)Malignant and accelerated hypertensive.

5)Patients having chronic complications of Diabetes Mellitus ,Microvascular: Nephropathy,Macrovascular: Coronary artery disease (Acute or recent MI), Acute Peripheral vascular disease & Acute Cerebro-vascular episode. And acute complications like Prameha Pidaka (non-healing wound), extensive Localized or systemic virulent infection, Diabetic ketoacidosis.Other chronic debilitating diseases like STD etc,HIV positive cases,Secondary Diabetes mellitus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-evaluation of efficacy. <br/ ><br>Evaluation of duration response relationship on glycemic control. <br/ ><br>Timepoint: Baseline,From 1st week to 24 weeks fortnightly

Secondary Outcome Measures