In Vivo and Clinical Study of Daruharidra Ghan Vati in Sthula Madhumeha that is Diabetes Mellitus

Phase 2

Completed

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

Registration Number: CTRI/2019/01/017270

Lead Sponsor: SUSHIL VILAS CHAWRE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. The patients having fasting plasma sugar level more than or equal to 126mg/dl and post prandial plasma sugar level more than or equal to 200mg/dl (A.D.A 2016)

2. The patients fulfilling criteria of diagnosis and having clinical features of Sthula Madhumeha (Diabetes Mellitus)

3. Patients having BMI more than 23Kg/m2 up to 30Kg/m2 will be selected.

4. HbA1c is 6.5%up to 10%.

5. Patients having age between 30years to 70 years.

6. Those are willing to participate in trial and ready to give their written consent.

Exclusion Criteria

1. Patients who already taking anti-diabetic drugs.

2. Patients with fasting plasma sugar level >250mg/dl and post meal plasma sugar level >350mg/dl.

3. Patients having insulin dependent diabetes mellitus and juvenile diabetes and various other types of diabetes except Type II DM.

4.Patients having BMI less than 23kg/m2 and More Than 30kg/m2.

5. HbA1c more than 10%.

6. Patients having age below 30 years and above 70 years.

7. Patients who are currently participating in any other clinical trials since last 6 months. 8. Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.

9. Patients having other systemic complications like hepatic, renal and cardiac problems.

10. Patients having poorly controlled blood pressure.

11. Pregnant and lactating females not included in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the effect of Daruharidradi Ghanavati in Streptozotocin induced diabetes Mellitus in Wister rats specifically on blood sugar level. <br/ ><br>2.To study the effect of Daruharidradi Ghanavati on Sthula Madhumeha with specific reference to type II diabetes mellitus, on fasting and post prandial plasma sugar level and HbA1c,and to compare its effect with metformin.Timepoint: 1.In Animal study-In Rats anti diabetic effect will be assessed after one month.. <br/ ><br>In Clinical trial - <br/ ><br>1.On zero day i.e. before treatment value. <br/ ><br>2.In trial group Daruharidradi Ghan Vati 500mg twice a day and in control group tablet Metformin 500mg twice a day will be given for 3months. <br/ ><br>3.Follow up and assessment will be done on every 15days after starting medicine up to 90 days. <br/ ><br>4.Final assessment will be done on ninety first day.

Secondary Outcome Measures

Name	Time	Method
1. To study the toxic effects of Daruharidradi Ghanavati by investigating LFT, KFT and relevant histo-pathological investigations in Swiss Albino mice. <br/ ><br>2. To study the literature of Madhumeha as per Ayurvedic perspective. 3. To study the literature of Diabetes Mellitus.Timepoint: 1.The oral chronic effect of Daruharidradi Ghan vati and Metformin in Swiss albino mice will be assess on ninety first day. <br/ ><br>2. The assessment of all study will be evaluate after completion of study.