A Comparative Study To Evaluate The Efficacy Of Phalatrikadi Churna Along With Dietery Modification And Musta Churna In The Management Of Medodushti (Dyslipidemia) A Randomized Controlled Open Label Clinical Trial

Research Question

What Is The Efficacy Of Phalatrikadi Churna Along With Dietary Modification, Compared With Musta Churna Among 21-60 Year Patients In The Management Of Medodushti (~Dyslipidemia)?

Hypothesis

Null Hypothesis (H0)

Oral Administration Of Phalatrikadi Churna Is Not More Effective Compared With Musta Churna In The Management Of Medodushti.

Alternate Hypothesis (H1)

Oral Administration Of Phalatrikadi Churna Is More Effective Compared With Musta Churna In The Management Of Medodushti.

Need Of The Study

Dyslipidemia Disease Has Become A Growing Global And Public Health Concern Among Non[1]Communicable Diseases (Ncds). Although Modern Medicines Like Atorvastatin Have Been A Successful Remedy But Its Long-Term Use May Result In Side Effects. On The Other Hands, Ayurveda Believes That Dyslipidemia Is Mainly Due To Kapha Dosha And Medo-Dhatu And Deal With It In Varieties Of Ways Like Langhan, Vaman, Virechan, Basti & Shaman And Thus An Attempt Has Been Made An Oral Administration Of Phalatrikadi Churna For Correction Of Medodushti (~Dyslipidemia). All Drugs Are Available And Palatable. Both The Drugs, Phalatrikadi Churna And Musta Churna Are Having Ruksha, Laghu Guna Properties Predominantly Are Being Selected To Evaluate Their Therapeutic Effect In Samprapti Vighatana By Cleansing The Ama, Kapha Dosha And Meda And Hence Can Help In Management Of Medodushti (~Dyslipidemia).

 Study Objectives

Primary Objective

1)     Significant Favourable Change In Level Of Dyslipidemia Index

2)    Improvement In The Signs And Symptoms Of Medoroga.

Secondary Objective

1)        1) To Improve The Quality Of Life SF 36

2)             2) Monitoring The Effect Of Therapeutic Intervention On KFT, LFT

3)             3)  Potential To Record Unexpected Adverse Events.

   Inclusion Criteria

1. Patients Between The Age Group Of 21-60 Years Of Either Sex.

2. BMI  >25 Kg/M2

3. Willing And Able To Participate In The Study For 1month.

4. Patients Having Abnormal Lipid Profile Eg T.Cholesterol >200 And T.Cho/HDL >4.5.

5. Patients With Strictly Controlled Diabetes Mellitus (Hba1c Less than equals to 6.5percent).

6. Patient With Pratyatma Lakshan Of Medodushti.

7.Patients Not Taking Any Lipid Lowering Drugs For The Past One Month.

8. Ability To Adhere To Study Duration.

 Exclusion Criteria

1. Patients With Poorly Controlled Diabetes Mellitus (Hba1c >6.5%) And Hypertension (BP >160 / 100 Mm Hg)

2. Pregnant / Lactating Woman

3. BMI >39.9kg/M2

4. Patients With Genetic Syndromes, Severe Cardiovascular Disease (Cad, CAD, MI, Unstable Angina, Uncontrolled Hypertension) Or Any Other Life-Threatening Condition.

5. History Of Hypersensitivity To Any Of The Trial Drugs Or Their Ingredients.

6. Patients Having Systemic Illness Which Will Interfere With The Course Of Procedure.

7. Patients Who Are Already Enrolled In Other Study.

 Investigations –

To Be Done At Two Levels

Before Treatment

After Treatment

1. CBC With ESR.

2. Lipid Profile.

3. Liver Function Tests.

4. Kidney Function Tests.

5. Thyroid Function Test

6. Hba1c

7. Blood Sugar (FBS And PP)

8. Urine- Routine And Microscopic Examination.

9. Apolipoprotein (In The Specific Patient Population) Only If Available

 Assessment Criteria

Objective Criteria

1) Total Serum Cholesterol Greater Than Or Equal To 200mg/dl Or

2. Serum Triglycerides Greater Than Or Equal To 150mg/dl Or 11

3. Serum LDL Cholesterol Greater Than Or Equal To 130 Mg/dl Or

4. Serum HDL Cholesterol Less Than 40mg/dl In Males And Less Than 50 Mg/dl In Females

5. Serum VLDL Cholesterol– 41mg/dl Or More

Subjective Criteria

1) Improvement In The Signs And Symptoms Of Medoroga

  2) To Improve The Quality Of Life Sf 36