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CTRI Number  CTRI/2010/091/000368 [Registered on: 28/04/2010]
Last Modified On: 10/03/2013
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study
Modification(s)  		 Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A clinical trial to assess the efficacy and safety of poly-herbal formuation "NARSIMHA" in comparison with Atorvastatin in hyperlipimedic men and women. 
Scientific Title of Study
Modification(s)  		 A phase III, double blind, randomised, parallel design, controlled clinical study to assess and compare the lipid-lowering effects and safety of poly-herbal formulation "NARSIMHA" with Atorvastatin in hyperlipidemic men and women.  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Nitin Patki 
Designation   
Affiliation   
Address  Deenanath Mangeshkar Hospital & Research Centre
Erandwane
Pune
MAHARASHTRA
411004
India 
Phone  02040151000  
Fax  02025420104  
Email  nitin1patki@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Nitin Patki 
Designation   
Affiliation   
Address  Deenanath Mangeshkar Hospital & Research Centre
Erandwane
Pune
MAHARASHTRA
411004
India 
Phone  02040151000  
Fax  02025420104  
Email  nitin1patki@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Nitin Patki 
Designation   
Affiliation   
Address  Deenanath Mangeshkar Hospital & Research Centre
Erandwane
Pune
MAHARASHTRA
411004
India 
Phone  02040151000  
Fax  02025420104  
Email  nitin1patki@gmail.com.org  
 
Source of Monetary or Material Support
Modification(s)  
M/s Nisarga Biotech Pvt Ltd 275 Chandan Nagar Addnl MIDC SATARA 415004 Phone 02162240438 Fax 02162240439 email: krushitek@vsnl.com & soman.girish@gmail.com 
 
Primary Sponsor
Modification(s)  
Name  Nisarga Biotech Pvt Ltd  
Address  275 Chandannagar Adnl MIDC SATARA MS India 415004 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL  NA 
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitin Patki  Deenanath Mangeshkar Hospital & Research Centre  Erandwane
Pune
MAHARASHTRA 		 02040151000
02025420104
nitin1patki@gmail.com.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Hyperlipidemia in men & women,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  ATORVASTATIN  Atorlip tab 10mg od for 3 months 
Intervention  NARSIMHA  450mg bid for 3 months 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) The subject of 30-70 years of age of either sex with established hyperlipidemia
2) Free of obvious health problems as established by medical history and physical examination.
3) The subject willing to give written informed consent and willing to comply with study protocol.
4) The subject not received lipid lowering drugs at least 3 months prior to recruitment.
 
 
ExclusionCriteria 
Details  1) The subject with cardiovascular disease, diabetes mellitus, chronic inflammatory diseases, untreated hypertension (> 140/95 mm Hg) or liver/renal disease.
2) Subject participating in other clinical trial or planned participation in another clnical trial during the present trial period.
3) The Subject with H/o smoking or the subject receiving anti-inflammatory or lipid-lowering medication.
4) The subject with diseases demanding continuous administration of B-blockers, calcium antagonists, hypoglycemic agents or diuretics.
5) History of a previous severe allergic reaction (generalized urticaria; angioedema or anaphylaxix), chronic alcohol consumption and/or intravenous drug abuse.
6) Pregnant and lactating women.
7) History of contraceptive, harmone replacement therapy (HRT) or steroids since last 3 months.
8) Subjects with history of tuberculosis, HIV or malignancy.
 
 
Method of Generating Random Sequence
Modification(s)  		 Permuted block randomization, fixed 
Method of Concealment
Modification(s)  		 Pre-numbered or coded identical Containers 
Blinding/Masking
Modification(s)  		 Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Efficacy  Measured on Day 1, 45, 90 & 120. 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Safety  Measured on Day 1, 45, 90 & 120. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="80"
Sample Size from India="80" 
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
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 Date Missing 
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
Modification(s)  		 Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 A phase III, double blind, randomized, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARSIMHA" is undertaken in 80 hyperlipidemic patients of 30 to 70 years of age. The trial shall be conducted at: Deenanath Mangeshkar Hospital & Research Centre, Pune. Treatment will be given for 3 months. Atorvastatin shall be used as a comparator (active controlled) drug. Efficacy of the drug will be evaluated based on visits on day (-7), 45, 90 & 120. 
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