Plan of work

After Institutional Ethics Clearance of Government Ayurved College, Nagpur Screening of Population will be done from Patients in OPD, IPD of our hospital attached to institute. In the Clinical study 60 Patients of Medoroga with Hyperlipidemia will include. Assessment of lipid profile and clinical symptoms of Medoroga will be done. If patient fulfill the criteria of inclusion, subject would also give freedom to ask the questions and all questions would answer. If he/she agrees for participation in the study and found fit to include then that patient will be included in a study.

The treatment will be given to patient as follows:

Group A (Trial Group)

1) 0 Day assessment (Before treatment) on recruitment day

2) Udvartana with Mustadi Churna At morning before bath for 20 mins daily (for 15 days)  + Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (for 15 days)

3) Mid treatment assessment (on 16^th day) Udvartana with Mustadi Churna At morning before bath for 20 mins daily (for next 15 days) + Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal For next 15 days

4) Assessment after completion of treatment (On 31^st day)

Group B(Control Group)

1)0 Day assessment (Before treatment) on recruitment day

2)Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (for 15 days)

3)Mid treatment assessment (on 16^th day)

4)Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (For next 15 days)

5)Assessment after completion of treatment (On 31^st day)

Medium of Dissertation: The dissertation will be written in English by using Ayurvedic terminology where ever necessary in Sanskrit.

Study Setting: OPD and IPD of hospital attached to institute.

Study Design: Randomized Controlled Trial

Duration of study: 18 months

Duration of Treatment: 30 days

Ethical Clearance: Clearance from Institutional Ethics committee of our Institute

Study Population:

All obese patients attending OPD, IPD of our institute will be considered in this study.

Patients in between age group of 20 – 70 years.

Patient will be diagnosed on the basis of lipid profile and symptoms of Medoroga according to Ayurvedic Classics.

Sample Size:

Sample size was calculated with the help of data published by Nadkarni MA, Vyas SN, Baghel MS, Ravishankar B. Randomized placebo-controlled trial of Mustadi Ghanavati in hyperlipidaemia.

Required Sample Size per group is 26

Considering 10% dropout/non-response, Hence Final Sample Size in each group is 30.

Physical characters will be assessed on the basis of following Questionnaires and Scales:

A)     OBJECTIVE CRITERIA:

1] ANTHROPOMETRIC CHARACTERS

1.Height                                                                        

             2.Weight                                                                                                 

             3.BMI                                                                               

             4.Abdominal circumference                                         

             5.Waist circumference                                         

6.Hip circumference                                               

             7.Waist Hip Ratio

8.Skinfold Thickness - a. Abdominal   b. Bicep    c. Triceps

2] CLINICAL PARAMETERS:

1.SPO2

2.Pulse Rate

3.Respiration Rate

4.Blood Pressure

5. Temperature

3] BIOCHEMICAL PARAMETERS:

            1. Lipid profile

            2. Blood sugar level fasting and Post Prandial

            3. Complete blood count

            4. Erythrocytes sedimentation rate

            5. Urine routine and microscopic

B)     OBJECTIVE CRITERIA:

1] Symptoms of Medoroga

2] Lipid Profile

3] BMI

4] Waist hip ratio, abdominal circumference and skin folds (abdominal, biceps & triceps)