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
|
|
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
|
|
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. |