| CTRI Number |
CTRI/2020/03/023890 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
09/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Udwartana followed by Virechana in Dyslipidemia, a Clinical Study |
|
Scientific Title of Study
|
A randomized open labelled comparative clinical study to evaluate the efficacy of Virechana with and without Snehapurva Rukshana in the management of Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reeny Ravina Dias |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Panchakarma, Sri Sri College of Ayurvedic Science and Research, 21st km, Kanakapura road, Bengaluru
#303, Sri Shankara Meadows,
O. B. Choodanahalli, Udipalya Post,
Bengaluru - 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7019176536 |
| Fax |
|
| Email |
reenyravina16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Puttur |
| Designation |
Professor and H.O.D |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG studies in Panchakarma, Sri Sri College of Ayurvedic Science and Research, 21st km, Kanakapura road, Bengaluru
#532, 7th A main, 11th D cross, Balaji layout, Vajarahalli, Kanakapura road, Bengaluru - 560062
Bangalore
KARNATAKA
560082
India |
| Phone |
9448176059 |
| Fax |
|
| Email |
drganeshputtur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reeny Ravina Dias |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bengaluru |
| Address |
Department of PG Studies in Panchakarma, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura road, Bengaluru
#303, Sri Shankara Meadows,
O. B. Choodanahalli, Udipalya Post,
Bengaluru - 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7019176536 |
| Fax |
|
| Email |
reenyravina16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research, 21st km, Kanakapura road, Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Reeny Ravina Dias |
| Address |
Sri Sri College of Ayurvedic Science and Research, 21st km, Kanakapura road, Bengaluru 560082 |
| Type of Sponsor |
Other [Self] |
|
|
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 Reeny Ravina Dias |
Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru |
Room number 8,
OPD - Panchakarma,
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km, Kanakapura road, Bengaluru 560082
Bangalore
KARNATAKA |
7019176536
reenyravina16@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 |
(1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
N/A |
| Intervention |
Virechana with Snehapurva Rukshana in Dyslipidemia |
Deepana - Pachana with trikatu choorna 1tsf 3 times a day with half glass warm water till nirama lakshana are seen.
Rukshana with udwartana till Samyak rukshana lakshanas are seen.
Snehapana with moorchita tila taila till Samyak snigdha lakshanas Are seen and dose will be decided based on the koshta and agni.
Abhyanga with Moorchita tila taila for 3 days.
Swedana with bashpa sweda for 3 days.
Virechana with Trivrt lehya, dose will be calculated based on the koshta of the patient. |
| Intervention |
Virechana without Snehapurva Rukshana in Dyslipidemia |
Deepana - Pachana with trikatu choorna 1tsf 3 times a day with half glass warm water till nirama lakshana are seen.
Rukshana with udwartana till Samyak rukshana lakshanas are seen.
Snehapana with moorchita tila taila till Samyak snigdha lakshanas Are seen and dose will be decided based on the koshta and agni.
Abhyanga with Moorchita tila taila for 3 days.
Swedana with bashpa sweda for 3 days.
Virechana with Trivrt lehya, dose will be calculated based on the koshta of the patient. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects diagnosed with dyslipidemia with any of the serum lipid levels,
S. Cholesterol - 200-500mg/dl
S. Triglycerides - 150-400mg/dl
HDL - <40mg/dl
LDL - 130-400mg/dl
Subjects fit for Snehapana, Swedana, Udwartana and Virechana
VLDL - 40-200mg/dl |
|
| ExclusionCriteria |
| Details |
Subjects unfit for snehapana, swedana, udwartana and virechana.
Subjects with type 1 diabetes, uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular diseases
Dyslipidemia due to endocrine or renal pathologies
Dyslipidemia due to drugs e.g. glucocorticoids etc
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Serum Lipid levels |
Before treatment,
After treatment - next day of Virechana,
On follow up - after 15 days of Samsarjana krama |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/03/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dyslipidemia is the most important atherosclerotic risk factor. Review of population based studies in India shows increasing mean total cholesterol levels. Recent studies reported that high cholesterol is present in 25-30% of urban and 15-20% of rural subjects. In modern science, Statins are the first choice in the treatment of Dyslipidemia, however the need for long term, lifelong therapy with statins is associated with several adverse effects like myopathy, increased risk of acute and chronic renal failure, hypothyroidism and memory loss. Thus, Considering the facts, A comparative clinical study is proposed to compare the efficacy of virechana with and without snehapurva rukshana in the management of dyslipidemia. |