Effect of Virechanakarma (Purgation therapy) in males having altered lipid levels in blood pertaining to Lingayat community
- Conditions
- Dyslipidemic diagnosed on NCEP ATP III criteria
- Registration Number
- CTRI/2013/10/004094
- Lead Sponsor
- IGIB New Delhi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 7
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in mRNA expression Changes in mRNA expression on day 1
- Secondary Outcome Measures
Name Time Method Changes in mRNA expression 12days
Trial Locations
- Locations (1)
PANCHAKARMA DEPARTMENT, ROOM NUMBER 4
🇮🇳Belgaum, KARNATAKA, India
PANCHAKARMA DEPARTMENT, ROOM NUMBER 4🇮🇳Belgaum, KARNATAKA, IndiaDrBSPrasadPrincipal investigator9448569289dr_bsprasad@rediffmail.com