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CTRI Number  CTRI/2018/01/011137 [Registered on: 04/01/2018] Trial Registered Retrospectively
Last Modified On: 03/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Effective Management Of High Cholesterol Level  
Scientific Title of Study   A Comparative Study To Analyze The Effect Of Kshara And Sneha On Hypercholesterolemia-A Kriyatmak Approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jalindar Dhamale 
Designation  Associate professor  
Affiliation  sri sri college of ayurvedic science and research, bangalore 
Address  Room no 202,Dept. of Kriya shareera,SSCSAR,21 st k.m.kanakapura road,udayapura bangalore

Bangalore Rural
KARNATAKA
560082
India 
Phone  8123463824  
Fax    
Email  drdhamale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jalindar Dhamale 
Designation  Associate professor  
Affiliation  sri sri college of ayurvedic science and research, bangalore 
Address  Room no 202,Dept. of Kriya shareera,SSCSAR,21 st k.m.kanakapura road,udayapura bangalore

Bangalore Rural
KARNATAKA
560082
India 
Phone  8123463824  
Fax    
Email  drdhamale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jalindar Dhamale 
Designation  Associate professor  
Affiliation  sri sri college of ayurvedic science and research, bangalore 
Address  Room no 202,Dept. of Kriya shareera,SSCSAR,21 st k.m.kanakapura road,udayapura bangalore

Bangalore Rural
KARNATAKA
560082
India 
Phone  8123463824  
Fax    
Email  drdhamale@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences,4th T block,Jayanagar,Bangalore,Karnataka 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  RGUHS 4th T block jayanagar bangalore 
Type of Sponsor  Other [university for health sciences ] 
 
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 
Dr Jalindar Dhamale  Sri Sri Ayurveda Hospital  21st KM Kanakpura Road Udayapura Post Bangalore 560082
Bangalore Rural
KARNATAKA 
8123463824

drdhamale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sri sri institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  hypercholesterolemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  kshara  kshara has scraping effect on cholesterol 1 gram twice daily orally for 7 days 
Intervention  sneha  sneha also lowers cholesterol goghrita is given orally dosage 20 ml for 7 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Known cases of hypercholesterolemia.
Persons who are not habituated to take ghee.
 
 
ExclusionCriteria 
Details  1)Individuals with the history of any systemic and mental disorders.
2)Individuals taking internal medication which affects fat metabolism.
3)Individuals habituated to take ghee.
4)Women who are consuming oral contraceptive pills.
5)Pregnant and lactating women.
6)Alcoholics and smokers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
lowering the values of lipid profile  assessment of objective parameters on 0 day and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
lowering the values of lipid profile  assessment of objective parameters on 21st day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/10/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   "none yet" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hypercholesterolemia is one the leading high risk factors for various cardiovascular disorders, which has become a serious life threatening causative factor for various lifestyle disorders.

Different therapeutic measures which needs to be adopted to cut down this risk factor is a major requirement in the present scenario. So the need of the hour is to tackle this burning issue through holistic, conventional, and cost effective approach so as to reach the common man.

In Ayurveda, various siddhanta’s have been stated. Based on “samanya vishesha siddhanta” and “panchabhoutika siddhanta” paneeya kshara should reduce the serum cholesterol level. In ayurvedic classics there is clear indication of paneeya kshara in medorogas.  When viewed from the panchabhoutik aspect, cholesterol is having pruthvi and jala mahabhuta pradhanyata. When Tejo mahabhuta pradhana kshara is administered there occurs vilayana (disintegration) of the cholesterol.

Ghee is considered to be an integral part of the human diet in India since ages. Ghee has good nutritious and therapeutic value. Ayurveda suggests the use of goghrita as shreshtha. Based on the concept of “hetu vipareetarthakari upashaya” many studies have already proved that by the consumption of sneha there is a reduction in the cholesterol level. Sneha is also having pruthvi and jala mahabhuta pradhanyata.

So the present study is to compare the effect of kshara and effect of sneha on hypercholesterolemia – wherein the karmukata of 2 viruddha guna yukta dravyas are same. 
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