| CTRI Number |
CTRI/2019/03/018228 [Registered on: 22/03/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study theeEffect of an Ayurvedic Drug Trimurthy Ras for treatment of Medoroga (Dyslipidaemia - Blood fat levels) |
|
Scientific Title of Study
|
Pharmaceutico - Clinical validation of Trimurthy Ras in the management of Medoroga (Dyslipidaemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ratna Priya Darsini Y |
| Designation |
Assistant Professor |
| Affiliation |
Dr.N.R.S Govt Ayurvedic College |
| Address |
Dept of Kaya chikitsa Dr NRS Govt Ayurvedic College M G Road Vijayawada Andhra Pradesh India
GF4 Gold Block Sai Nivas Residency Near Ayyappa Temple Gollapudi Vijayawada Rural Krishna District Andhra Pradesh
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9440353825 |
| Fax |
08662576922 |
| Email |
dr.ratnapriyadarsini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babu G |
| Designation |
Assistant Director I/C |
| Affiliation |
Regional Ayurveda Research Institute for Skin Diseases, (a unit of CCRAS) |
| Address |
Regional Ayurveda Research Institute for Skin Diseases (a unit of CCRAS)
New Rajeev Nagar Payakapuram
VIJAYAWADA
Regional Ayurveda Research Institute for Skin Diseases (a unit of CCRAS)
New Rajeev Nagar Payakapuram
VIJAYAWADA
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
8096455323 |
| Fax |
08662402535 |
| Email |
drbabugajji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratna Priya Darsini Y |
| Designation |
Assistant Professor |
| Affiliation |
Dr.N.R.S Govt Ayurvedic College |
| Address |
Dept of Kaya chikitsa Dr NRS Govt Ayurvedic College M G Road Vijayawada Andhra Pradesh India
GF4 Gold Block Sai Nivas Residency Near Ayyappa Temple Gollapudi Vijayawada Rural Krishna District Andhra Pradesh
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9440353825 |
| Fax |
08662576922 |
| Email |
dr.ratnapriyadarsini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ratna Priya Darsini Y
GF 4 Gold Block Sainivas Residency Gollapudi Vijayawada Rural Pin 521225 |
|
|
Primary Sponsor
|
| Name |
Dr Ratna Priya Darsini Y |
| Address |
GF 4 Sai Nivas Residency Near Ayyappa Temple Gollapudi Vijayawada Rural Krishna District Andhra Pradesh India |
| 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 Ratna Priya Darsini Y |
Dr NRS Govt Ayurvedic College and Hospital M G Road Vijayawada Krishna Andhra Pradesh |
Room No 5 Department Of Kaya Chikitsa, DrALGovt Hospital
Krishna
ANDHRA PRADESH |
9440353825
08662576922
dr.ratnapriyadarsini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E782||Mixed hyperlipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Triglize |
A group of 50 patients are administered with Triglize 500mg tablets twice daily for 90 days and the subjective and objective parameters are observed |
| Intervention |
Trimurthy Ras |
50 patients will be administered with Trimurthy Ras per oral 500 mg twice daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 18-60 years will be taken for the study.
Patients of either sex with Hyperlipidaemia.
Patients with abnormal (borderline high to high) lipid level in blood serum, as per the ATP –III classification
|
|
| ExclusionCriteria |
| Details |
Age below 18 years and 60 years
Known/diagnosed cases of severe renal disease, hepatic disease, coronary heart disease or myocardial infarction and other systemic diseases.
Uncontrolled hypertension, diabetes mellitus and malignancy patients
Undergoing treatment for any other serious illness
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms and significant improvement of objective parameters tests to 50% baseline |
Relief in signs and symptoms and significant improvement of objective parameters assessed at 0 30 60 and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Plasma Total Trigicerides, Total Cholesterol, HDL and LDL values |
Treatment period of 90 days
Assessment for every 30 days withactive followup of 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/12/2019 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A clinical trial is done to evaluate the efficacy of the ayurvedic formulation Trimurthy Ras in the management of Medoroga vis-a-vis dyslipidaemia and to validate scientifically the observations that would significantly change the lipid and lipoproteins levels in the plasma and also relief in signs and symptoms of dyslipidaemias. Trimurthy Ras is aunique formula of Herbo- minerals which has its reference from an authentic Ayurvedic Classical texts Yoga Ratnakaram and Bhasavaraajeeyam is given on 50 patients orally 500mg twice daily for 90 days and to compare the observations with other group in which Triglize is administered in 50 patients 500mg twice daily for 90 days. The study would be conducted in India aimed to complete in 3 years and the trial time being 21 momths. Primary outcome measures will be relief in signs and symptoms (Subjective Parameters) numberpatients with sustained change in Lipid profile values tests to 50% baseline Increased risk of death from cardio-vascular diseases can be significantly reduced Levels of elevated or abnormal lipids can be significantly brought under control and managed.P revention of complications like atherosclerosis, CAD, MI and CVA etc |