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CTRI Number  CTRI/2019/08/020739 [Registered on: 16/08/2019] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of two drugs karanjadi vati and rosuvastatin tablet in patient with medovridhhi or high Cholesterol level. 
Scientific Title of Study   A randomized controlled clinical study of karanjadi vati and rosuvastatin tablet in the management of medovridhhi with special reference to hyperlipidaemia. 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHISH GANGADHARRAO KECHE 
Designation  PhD SCHOLAR 
Affiliation  R. A. PODAR MEDICAL (AYU) COLLEGE MUMBAI-18 
Address  R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
Mumbai
MAHARASHTRA
400018
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr GEETA PARULKAR 
Designation  PROFESSOR 
Affiliation  R. A. PODAR MEDICAL (AYU) COLLEGE MUMBAI-18 
Address  R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
Mumbai
MAHARASHTRA
400018
India 
Phone  8652694332  
Fax    
Email  geeta.parulkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  ASHISH GANGADHARRAO KECHE 
Designation  PhD SCHOLAR 
Affiliation  R. A. PODAR MEDICAL (AYU) COLLEGE MUMBAI-18 
Address  R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA.
Mumbai
MAHARASHTRA
400018
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Source of Monetary or Material Support  
R.A.PODAR MEDICAL (AYU) COLLEGE AND M.A. PODAR HOSPITAL MUMBAI-18. 
 
Primary Sponsor  
Name  ASHISH KECHE 
Address  R.A PODAR MEDICAL (AYU) COLLEGE, DR.ANNIE BESANT ROAD,WORLI,MUMBAI. MAHARASHTRA. 
Type of Sponsor  Other [R.A. PODAR MEDICAL (AYU) COLLEGE MUMBAI.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ASHISH KECHE  M. A. PODAR HOSPITAL   ROOM NO 17, KAYACHIKITSA DEPARTMENT,M.A.PODAR MEDICAL (AYU) COLLEGE,DR. ANNIE BESANT ROAD, WORLI, MUMBAI -18.
Mumbai
MAHARASHTRA 		 8149921892

rajeashish09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
institutional ethics commitee  Approved 
institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Karanjadi Vati  500mg vati with warm water before meal twice a day 
Comparator Agent  Rosuvastatin tablet  10mg with simple water before bed time once a day 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patient having Serum LDL Cholesterol Level above 190mg/dl.
2) According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% of CHD whose LDL Cholesterol goals not achieve (≥160mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).
3) According to NCEP ATP III, Patient having multiple (+2) risk factor with 10 year risk of 10% to 20% of CHD whose LDL Cholesterol goals not achieve (≥130mg/dl) after 12 weeks Therapeutic lifestyle changes (TLC).
 
 
ExclusionCriteria 
Details  1) Patient with Multiple (+2) risk factor with 10 year risk 10% of CHD, who achieve the goal of LDL Cholesterol (≤160mg/dl) after TLC therapy.
2) Patient with Multiple (+2) risk factor with 10 year risk 10% to 20% of CHD, who achieve the goal of LDL Cholesterol (≤130mg/dl) after TLC therapy.
3) Pregnant women and lactating mothers.
4) Patients having history of Renal Disease, Liver Disease.
5) Patients having Recently 3 month history of Heart Failure or Stroke.
6) Patients having disorders like Carcinoma etc. anywhere in the body.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
value of LDL and signs and symptoms of hyperlipidaemia (Medovridhhi).  3 year 
 
Secondary Outcome  
Outcome  TimePoints 
SAFETY AND EFFICACY OF KARANJADI VATI AND ROSUVASTATIN TABLET  3 years 
 
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   Phase 2 
Date of First Enrollment (India)   19/08/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NOT YET DONE 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This is a randomized controlled open labelled parallel group clinical trial comparing the safety and efficaccy of karanjadi vati and rosuvastatin tablet.

Null hypothesis (H0): Karanjadi Vati and Rosuvastatin Tablet are equally effective in the management of Medovriddhi W.S.R. to Hyperlipidaemia.

 

Alternative hypothesis (H1): Karanjadi Vati and Rosuvastatin Tablet are not equally effective in the management of Medovriddhi w.s.r. to hyperlipidaemia.

In patient having multiple (+2) risk factor with 10 year risk of ≤10% & 10%-20% whose LDL cholesterol goals not achieve (≥160mg/dl & ≥130mg/dl respectively) after TLC Then in drug therapy, Will Karanjadi Vati 500 mg twice a day after food with koshna Jala and Rosuvastatin tablet 10mg once a day at bed time daily for 6 weeks are equally effective in the management of Medovriddhi with special reference to Hyperlipidaemia ?

 
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