Managemaent Of Dyslipidemia With Vamana Karma (Therapeutic emesis) a Biopurificatory procedure

Phase 3

Completed

• Conditions: Patients suffering with dyslipidemia and having clinical features of medoroga

• Registration Number: CTRI/2018/02/011886
• Lead Sponsor: National Instititute of Ayurveda

Brief Summary

The present clinical study entitled “A comparative clinical study on the effect of *Vamana Karma* with *Dhamargava* and *Vatsaka Beeja* followed by *Lekhaneeya Ghana* *Vati* in the management of *Medoroga* w.s.r to Dyslipidemia†was carried out in 30 patients divided in 2 groups. In both the groups patients were treated with *Vamana Karma* with two different drugs followed by *Shamana Auashadi* with the following aims and objectives.

**Aims & Objectives:**

·               To evaluate the effect of *Vamana Karma* with *Dhamargava Yoga* and *Lekhaniya ghana vati* in the management of  Dyslipidemia.

·               To evaluate the effect of *Vamana Karma* with *Vatsaka Beeja Yoga* and *Lekhaniya ghana vati* in the management of Dyslipidemia.

·               To compare the effect of *Vamana Karma* with *Dhamargava Yoga* and *Vatsaka Beeja Yoga* in the management of Dyslipidemia.

**Materials and methods:**

**Materials:**

**Clinical study materials:** 30 patients.

**Source of data:** Patients indicated and fit for trial were selected from outpatient and inpatient department of *Panchakarma,* National Institute of Ayurveda Hospital, Jaipur.

**Conceptual study materials:** Books, internet, journals.

**Drugs used in the trial:**

Allthe medicines were procured from National Institute of Ayurveda Pharmacy, Jaipur, except *Dhamargava phala* which was collected from jalagaon dist. Maharashtra.

**Methods:**

**Research design:**

A comparative randomized clinical study.

**Statistical method:** Student paired and unpaired t test, Wilcoxon test, Manwhitney U test.

**Method of collection of data:** Patients were thoroughly examined both subjectively and objectively. Detailed history pertaining to previous ailment, previous treatment history, family history, habits, physical examination and systemic examination findings were noted.  Routine investigations were carried out to exclude other systemic pathology. Subjects were registered in the clinical trial and detail information was documented in the case proforma prepared for the study.

**Patient   consent:** In the respective group, the treatment procedure with its different steps and the outcome is properly explained in detail to the patients, written consent from the patients was obtained before enrolling in the clinical study.

**Diagnostic criteria:**

1.      Abnormal levels ofserum lipid profile.

2.      Clinical features of Dyslipidemia and *Medoroga* like *Ashaktaha Sarva Karmasu, Kshudra Shvasa, Svedadhikya, Utsahahani, Angagaurava.*

**Inclusion criteria**

·         Aged between 20-60 yrs.

- Serum lipid levels more than normal ranging from:

S.cholesterol (201mg/dl or more)

S.Triglycerides (161mg/dl or more)

Serum LDL (131mg/dl or more)

Serum VLDL (41mg/dlor more)

·         Having clinical features of *Medoroga*

·         Fit for *Vamana Karma*

**Exclusion criteria**

- Age below 20 years & above  60 years.

·         Associated with serious illness like Carcinoma Cardiac Failure, Malignant Hypertension.

·         Not fit for *Vamana Karma*.

**Laboratory investigation**

Following investigation will be carried out before & after treatment;

·         Routine blood investigation.

·         ECG to rule out Cardiac Pathology.

·         Lipid profile.

·         Routine urine analysis.

**Assessment criteria**

**A) Objective parameters:**

Objective criteria were mainly assessed on the basis of biochemical investigations like lipid profile (in selected patients) and also body weight, BMI  and waist hip ratio, before starting the treatment and after completion of treatment  were assessed in terms of percentage relief and statistical evaluations.

**1.** **Lipid profile:** Complete profile including serum cholesterol, serum triglycerides, serum HDL, serum LDL, serum VLDL were assessed

**2.** **Body weight****:** It was assessed by using weighing machine in kilograms

**3.** **Body mass index (BMI)****:** The body mass index (BMI) or Quetelet index is a statistical measurement which compares a person’s weight and height. The frequent use of the BMI is to assess how much an individual’s body weight departs from what is normal or desirable for a person of his or her height.

India has reworked the obesity guidelines by considering the alarming growth of abdominal obesity by lowering the BMI from 25 kg/m2 for overweight to 23 kg/m2.

(<http://www.igovernment.in/site/India-reworks-obesity-guidelines-BMIlowered/> accessed on 04/24/12)

**4.** **Waist-Hip ratio:** It is the ratio of the circumference of the waist to that of the hips. According to the world health organisation data gathering protocol, the waist circumference should be measured at the mid point between the lower margin of the last palpable rib and the top of the iliac crest, using a stretch –resistant tape  that provides a constant 100g tension. Hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor. WHO STEPS states that abdominal obesity is defined as a waist-hip ratio above 0.90 for males and 0.85 for females.

**B) Subjective parameters:**

Signs and symptoms of *Medoroga* were used for symptomatic evaluation for which a multidimensional scoring pattern was adopted. The patients were assessed  by giving a score before and after *Vamana Karma* and after *Shamana Aushadi*  according to the severity of the symptoms.

The below following four parameters were assessed.

***1.*** ***Sarva Karmasu Ashaktata***

***2.*** ***Kshudra Shvasa***

***3.*** ***Svedadhikya***

***4.*** ***Dourbalya***

**Overall effect of the treatment:**

In Group A (*Vamana Karma* with *Dhamargava*) out of 15 patients, 39.96% patients had mild improvement, 13.32% patients had moderate improvement, 6.66% patients showed good improvement while 39.96% patients had no improvement after *Vamana.* After overall treatment 39.96% patients showed mild improvement, 6.66% patients had moderate improvement and 53.28% patient had no improvement.

In Group B (*Vamana Karma* with *Kutaja*) among 15 patients, 46.62% patients showed mild improvement, 6.66% each had moderate and good improvement. 39.96% patients had no improvement after *Vamana.* And after complete treatment 53.28% had mild improvement 6.66% had moderate improvement and 39.96% had no improvement.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-04
• Study Completion: 2015-01-29
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1 Serum lipid levels more than normal ranging from: S.cholesterol (201 mg/dl or more) S.Triglycerides (161 mg/dl or more) Serum LDL (131mg/dl or more) Serum VLDL (41mg/dl or more) 2 Having clinical features of Medoroga 3 Fit for Vamana Karma.

Exclusion Criteria

• 1 Age below 20 years & above 60 years.
• 2 Associated with serious illness like Carcinoma Cardiac Failure, Malignant Hypertension.
• 3 Not fit for Vamana Karma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Both groups showed significant improvement and result of intergroup comparision was non significant	9 months

Secondary Outcome Measures

Name	Time	Method
on an average weight reduction upto 5 kg	wt reduction was observed within 2 months of trial duration

Trial Locations

Locations (1)

National Institute of Ayurveda Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda Hospital

🇮🇳Jaipur, RAJASTHAN, India

sangeeta sharma

Principal investigator

08764322916

sinoliasangeeta1981@gmail.com