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CTRI Number  CTRI/2013/10/004094 [Registered on: 23/10/2013] Trial Registered Retrospectively
Last Modified On: 29/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  
Effect of Virechanakarma (Purgation therapy) in males having altered lipid levels in blood pertaining to Lingayat community  
Scientific Title of Study   An open clinical trial to explore the effect of Virechanakarma on mRNA expression in dyslipidemic males of Belgaum district 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSuma SSJoshi 
Designation  PG Scholar 
Affiliation  KLEUs Shri BMK Ayurveda Mahavidyalaya 
Address  KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  9449515046  
Fax    
Email  sumamaski@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSuma SSJoshi 
Designation  PG Scholar 
Affiliation  KLEUs Shri BMK Ayurveda Mahavidyalaya 
Address  KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  9449515046  
Fax    
Email  sumamaski@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSuma SSJoshi 
Designation  PG Scholar 
Affiliation  KLEUs Shri BMK Ayurveda Mahavidyalaya 
Address  KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
KLEUs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  9449515046  
Fax    
Email  sumamaski@gmail.com  
 
Source of Monetary or Material Support  
CSIR-Institute of Genomics and Integrative Biology Mall Road Delhi-110007 India 
 
Primary Sponsor  
Name  IGIB New Delhi 
Address  CSIR-Institute of Genomics and Integrative Biology Mall Road Delhi-110007 India 
Type of Sponsor  Research institution 
 
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 
DrBSPrasad  PANCHAKARMA DEPARTMENT, ROOM NUMBER 4  KLEUs Shri BMK Ayurveda Mahavidyalaya, Shahapur, Belgaum
Belgaum
KARNATAKA 
9448569289

dr_bsprasad@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLEUs Shri BMK Institutional Ethics Committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dyslipidemic diagnosed on NCEP ATP III criteria 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  before and after treatment details of mRNA involving expression  day 1 and day 12 of trial being analysed and assessed for the same 
Intervention  Deepana pachana with Hingwastaka churna, Snehapana with Panchatiktaguggulu ghrita, Sarvanga abhyanga with Triphaladya taila followed by Bhaspa sweda, Virechana with Trivrut lehya followed by Triphala kashaya as anupana given Samsarjanakrama  Dose: Hingwastaka churna- 1/2 tea spoon three times a day with hot water before food around 3 to 4 days Snehapana till attainment of Samyaka snigdha lakshanas around 2 to 3 days Sarvanga abhyanga with bhaspa sweda for three days Virechana for one day Samsarjanakrama based on shuddhi around 4 to 5 days Its an open clinical trail The subjects blood sample of dyslipidemic patients were taken for mRNA expression on day 1 and day 16 of trial Total duration varies from person to person. In the present study time taken was 16 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Male patients
Age group between 30-50years
From Belgaum district, specially lingayat community
Kapha predominant prakruti persons (assessed based on questionnaire) 2
Diagnosed Dyslipidemia based on NCEP ATP III criteria
 
 
ExclusionCriteria 
Details  Virechana anahra’s
Female patients
Male patients having associated disorders like
Diabetes
Hypothyroidism
Nephrotic syndrome
Obstructive liver disease
Chronic renal failure
Drugs(that may raise LDLcholesterol or cause other dyslipidemia)
– Progestins
– Anabolic steroids
– Corticosteroids
– Protease inhibitors for treatment of HIV infections
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in mRNA expression  Changes in mRNA expression on day 1  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in mRNA expression  12days 
 
Target Sample Size   Total Sample Size="7"
Sample Size from India="7" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="7" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/08/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dyslipidemia is the most common and widespread metabolic disorder, generally characterized by increased fasting concentrations of total cholesterol, low-density lipoprotein cholesterol, and triglycerides, in conjunction with decreased concentrations of high-density lipoprotein cholesterol.The prevalence of Dyslipidemia was observed to be higher in males than in females. A study shows that participants who had a total cholesterol (TC) concentration ≥ 200mg/dl, 38.7% were males and 23.3% were females. High density lipoprotein cholesterol (HDL-C) was abnormally low in 64.2% males and 33.8% in females3.The prevalence was observed to be in the age group between 30-45yrs. Regulation of lipid profile noticed with Snehapana6 and also with Virechanakarma7.Shodhanakarma removes the disease from its root. Hence there will be less chances of recurrence of diseases8.Thus here an attempt is made to study the action of Virechanakarma at genetic level.

MATERIALS AND METHODS

Source of data

Cases of Dyslipidemia fulfilling the NCEP ATP III criteria will be selected from outpatient and inpatient department of KLEU’s BMK Ayurveda Mahavidyalaya, Belgaum. The patients will be examined with the help of research proforma as prepared for this study on the basis of complaints and physical and systemic examination of the patient.

Method of collection of data

It is an open clinical trial

·         Fifteen men who meet NCEP ATP III criteria guidelines for dyslipidemia between the age group 30-45yrs will be recruited into the study.

·         Detailed physical examination of the patient will be done based on inclusion in the study.

·         Lipid profile and Gene expression of mRNA will be studied both before and after the treatment.

Inclusion criteria

a) Male patients

b) Age group between 30-45yrs3, 4

c) From Belgaum district, specially lingayat community

d) Kapha predominant prakruti persons (assessed based on questionnaire) 2

e) Diagnosed Dyslipidemia based on NCEP ATP III criteria.1

Exclusion criteria

·         Virechana anahra’s

·         Female patients

·         Male patients having associated disorders like

*      Diabetes

*      Hypothyroidism

*      Nephrotic syndrome

*      Obstructive liver disease

*      Chronic renal failure

*      Drugs(that may raise LDLcholesterol or cause other dyslipidemia)

– Progestins

– Anabolic steroids

– Corticosteroids

– Protease inhibitors for treatment of HIV infections

Intervention/Treatment

          After obtaining the written informed consent, 15 patients will be will given with

1.    For Deepana and Pachana : Hingwastaka choorna, Ushnajala as anupana. Deepana pachana means correction of the digestive fire. Its a prerequisite before snehana that is next step

2.    For Snehapana                          : Panchtiktaguggulu ghrita, Ushnodaka as anupana. Its oleation. It also involves two steps. Oleation internally and externally. Internally medicated ghee is given on empty stomach till the features which we call as "samyaka snigdha lakshanas" develop. Its time duration varies from person to person, 3 to 7days

3.    For Abhyanga                           : Triphaladi taila. Its oleation externally. Here whole body is massaged with medicated oil for 3-4days, based on the condition and its severity. Its followed with bhaspa sweda, a kind of sudation therapy.

4.    For Virechana                           : Trivrut leya, Triphala kashaya as anupana. Here purgation is given.

5.    Pathya during intervention         : Raktashali odana and mudga yoosha

6.    For Samsarjana                         :Peya, Vilepi, Mudga yoosha,The fourth samsarjana of      odana and mamsarasa was substituted by the   continuation of odana and mudga yoosha

         During and after treatment diet restrictions will be there. 

Drugs procured from KLE’s Ayurveda Pharmacy

Duration of the study    : 18months Statistical Analysis          : by Student’s t-test

Assessment criteria

1.    Lipid profile

2.    Genetic expression study of mRNA will be done with collaboration with IGIB New Delhi and Biotechnology Dept. of KLEU’s Engineering College

Clinical sample (Blood) collection:

Blood samples will be collected before the treatment and after the treatment with permission of the patient followed by taking signature of the patient on the standard consent form. The collected samples will be stored at -70 in PAX Gene tubes until further analysis. Samples from other places which are away from the research station will be transported to the research station according to state protocol for the transport of the clinical material.

Isolation of RNA from Blood samples:

Total mRNA will be isolated from blood samples stored in PAX Gene tubes, using PAX Gene blood RNA kit as per the manufacturers instructions.

Gene expression profiling:

The mRNA isolated from the blood will be converted to c DNA, with help of RT reaction kit. The gene specific TaqMan chemistry based probes will be designed for all the pathway specific genes which have shown the association with dyslipidemia. Using these probes gene expression profiling will be carried out by Real-Time PCR.

 
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