Ayurvedic Management on Type II Diabetes Mellitus.

Phase 2

Completed

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

• Registration Number: CTRI/2019/02/017609
• Lead Sponsor: Khobarkar Punam Self

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-05-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Newly detected patients having fasting blood sugar level more than 126mg/dl and post prandial blood sugar level more than 200mg/dl (A.D.A 2015)

2. Newly detected patients fulfilling criteria of diagnosis and having signs and symptoms of Sthula Madhumeha (Diabetes Mellitus)

3. Patients having age between 30 to 70 years

4. HbA1c up to 9%

5. Patients having BMI more than 23 will be selected up to 30 (chamukuttan.s.2006)

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

7. Patients with controlled Hypertension

Exclusion Criteria

1. Patients having age below 30 and above 70.

2. Patients with fasting blood sugar level >200mg/dl and post meal blood sugar level >300mg/dl.

3. HbA1c more than 9%.

4. Patients having BMI less than 23 and above 30.

5. Patients who already taken anti Diabetic drugs

6. Patients having insulin dependent diabetes mellitus and juvenile diabetes

7. Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.

8. Those are not willing to participate in trial and not ready to give written consent.

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

10. If any complication arises during treatment or if any patient discontinues the treatment these cases will be liable for rejection.

11. Patients having poorly controlled blood pressure.

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

13. Emergency cases in Type 2 Diabetes Mellitus.

14. Patients who are currently participating in any other clinical trials (since last 6 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the effect of Vidangadi Lauha on clinical features of Sthula Madhumeha ,blood sugar level,B.M.I. and hip waist ratio(Type II Diabetes Mellitus) and specifically on its parameters <br/ ><br>2. To evaluate the effect of Tab metformin on clinical features of Sthula Madhumeha (Type II Diabetes Mellitus) and specifically on its Parameters. <br/ ><br> 3. To compare the effect of drug in Trial Group Vidangadi Lauha with that of drug in Control Group Tablet Metformin 500mg.Timepoint: 1)On zero day assessments i. e. B.T. value <br/ ><br>2)For Trial group Vidangadi Lauha 5 gm BD before meal for 3 month <br/ ><br>3)For Control Group Tab. Metformin 500 mg BD before meal for 3 months <br/ ><br>4)Follow up assessment will be done on 31rst ,61rst, day and Data will be analyzed statisticaly. <br/ ><br>5)Final assessment will be done on 91rst day and statistical analysis will be done.

Secondary Outcome Measures

Name	Time	Method
1. To study the literature of Madhumeha as per Ayurvedic perspective. <br/ ><br>2. To study Madhumeha which is correlated with type 2 Diabetes mellitus with modern point of view. <br/ ><br> <br/ ><br>Timepoint: One and half year