| CTRI Number |
CTRI/2017/05/008600 [Registered on: 19/05/2017] Trial Registered Prospectively |
| Last Modified On: |
08/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Drug preparation and Clinical Study of Hrudayarnavaras its effect on excess Cholesterol |
|
Scientific Title of Study
|
Pharmaceutical and Clinical Evaluation of Hrudayarnavaras to its effect on Hyperlipidemia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Srinivas Naik |
| Designation |
Assistant Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College |
| Address |
Dr NRSGovt Ayurvedic College
Deprtment of Rasasastra
Vijayawada
Dr NRSGovt Ayurvedic College
Deprtment of Rasasastra
Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9441081268 |
| Fax |
|
| Email |
msnaik108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Srinivas Naik |
| Designation |
Assistent Professor |
| Affiliation |
Dr NRS Government Ayurvedic College |
| Address |
Dr NRS Govt Ayurvedic College
Deprtment of Rasasastra
Vijayawada
Dr NRS Govt Ayurvedic College
Deprtment of Rasasastra
Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9441081268 |
| Fax |
|
| Email |
msnaik108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Srinivas Naik |
| Designation |
Assistent Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College |
| Address |
Dr NRS Govt Ayurvedic College
Deprtment of Rasasastra
Vijayawada
Dr NRS GovtAyurvedic College
Deprtment of Rasasastra
Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9441081268 |
| Fax |
|
| Email |
msnaik108@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr M Srinivas Naik |
| Address |
Dr NRSGovt Ayurvedic College
Deprtment of Rasasastra
Vijayawada |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrMSrinivas Naik |
Dr NRSGovt Ayurvedic college |
M G ROAD NEAR V K SUPER BAZAAR
VIJAYAWADA 520002
Krishna
ANDHRA PRADESH |
9441081268
msnaik108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HyperLipidemia (excess Cholestrol) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HRUDAYARNAVA RAS |
125 mg b.i.d twice daily with triphala kwath |
| Intervention |
Hrudayarnava ras |
250 mg pills making and Oral administration two time in day a period of 90 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Hyperlipidemia
Angio graphically documented Coronary artery disease Radiological confirmation through Angiogram Doppler studies etc
Abnormalities present in ECG Echocardiography Stress test etc
|
|
| ExclusionCriteria |
| Details |
Age below 35 years
Recent MI less than three months
Patients with conduction problem
Patient with uncontrolled hypertension
Unstable Angina
Serious concomitant disease of liver and or kidney.Any malignancy Undergoing treatment for any other serious illness
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced levels of Lipid Profiles Arrest of the progress of condition into atherosclerosis
c) Prevention of complications like CAD, MI and CVA etc.
|
Reduced levels of Lipid Profiles
Arrest of the progress of condition into atherosclerosis
c) Prevention of complications like CAD, MI and CVA etc.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement generalcondition of the patient and can to their work easily |
treatment period 90 days followup treatment for every 30 days |
| To reduce the serum lipid levels |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2017 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
It will be published after completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed study was undertaken to investigate and establish the anti hyperlipidemic effect of a herbo mineral compound hrudayarnava ras the trial drug Hrudayarnava Rasa will be prepared in PG Deptof RS BK in Dr NRS Govt Ayurvedic College dosage125 mg twice in a day Anupanam Kakamachi and Triphala kashayam of 30 ml along tablet for a period of 90 days with investigations of serum cholesterol and lipid profile every 30 days period Data obtained from the present study is reproducible to avoid the batch to batch variation this Hrudayarnavaras sample preparing in a large quantity the values of physicochemical parameters can be taken for quality assurance
|