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CTRI Number  CTRI/2018/02/011886 [Registered on: 13/02/2018] Trial Registered Retrospectively
Last Modified On: 13/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Managemaent Of Dyslipidemia With Vamana Karma (Therapeutic emesis) a Biopurificatory procedure  
Scientific Title of Study   A COMPARITIVE 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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeeta Sharma 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda 
Address  Room No.12 Dept Of Panchkarma National Institute Of Ayurveda Amer Road Jaipur
S-84 Near Labour Court NBC Shantinagar Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  08764322916  
Fax    
Email  sinoliasangeeta1981@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Santoshkumar Bhatted 
Designation  Associate Professor 
Affiliation  National Institute Of Ayurveda 
Address  HOD Chamber Dept Of Panchkarma National Institute Of Ayurveda Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  08764322916  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Sangeeta Sharma 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda 
Address  Dept Of Panchkarma National Institute Of Ayurveda Amer Road Jaipur
S-84 Near Labour Court NBC Shantinagar Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  08764322916  
Fax    
Email  sinoliasangeeta1981@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur Rajasthan 
 
Primary Sponsor  
Name  National Instititute of Ayurveda  
Address  Amer Road Jaipur 302002  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
sangeeta sharma  National Institute of Ayurveda Hospital  Room no 12.Dept of Panchkarma Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 
08764322916

sinoliasangeeta1981@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering with dyslipidemia and having clinical features of medoroga,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vamana karma (Therapeutic emesis) with Dhamargava (Luffa cylindrica)  Vamana karma (Therapeutic emesis) with Dhamargava and lekhaneeya Ghana Vati in Follow up for 45 days. 
Comparator Agent  Vamana karma (Therapeutic emesis) with Kutaja beeja churna (Holarrhena antidysentrica)  Vamana Karma (Therapeutic emesis) with Kutaja beeja churna and Lekhaneeya Ghana Vati in follow up for 45 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Both groups showed significant improvement and result of intergroup comparision was non significant  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
on an average weight reduction upto 5 kg  wt reduction was observed within 2 months of trial duration 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/04/2013 
Date of Study Completion (India) 29/01/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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:

All the 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 of serum 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.

 
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