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CTRI Number  CTRI/2017/01/007642 [Registered on: 06/01/2017] Trial Registered Retrospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative effect of Lekhaniya Mahakashaya Ghan Vati and Mustadi Ghan Vati in the management of Dyslipidemia 
Scientific Title of Study   A comparative clinical study on Lekhaniya Mahakashaya Ghan Vati and Mustadi Ghan Vati 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  Rajneesh Pathak 
Designation  M.D.(Ayu) Scholar 
Affiliation  Govt Akhandanand Ayurved college Ahmedabad 
Address  Govt Akhandanand Ayurved College Bhadra Ahmedabad 380001
Govt Akhandanand Ayurved College Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India 
Phone  08866244063  
Fax    
Email  drrajneeshpathak5sept@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrakala R Pandit 
Designation  M.D.(Ayu) Professor 
Affiliation  Govt Akhandanand Ayurved college Ahmedabad 
Address  Department of Kaychikitsa Govt Akhandanand Ayurved college Bhadra Ahmedabad 380001
Department of Kaychikitsa Govt Akhandanand Ayurved college Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India 
Phone  09428241982  
Fax    
Email  dhanvantari4386@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajneesh Pathak 
Designation  M.D.(Ayu) Scholar 
Affiliation  Govt Akhandanand Ayurved College Ahmedabad 
Address  Govt Akhandanand Ayurved College Bhadra Ahmedabad 380001
Govt Akhandanand Ayurved College Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT
380001
India 
Phone  08866244063  
Fax    
Email  drrajneeshpathak5sept@gmail.com  
 
Source of Monetary or Material Support  
Govt Akhandanand Ayurved College Bhadra Ahmedabad 380001 and Maniben Ayurved Hospital Asarava Ahmedabad 
 
Primary Sponsor  
Name  Govt Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 
Address  Govt Akhandanand Ayurved College and hospital Bhadra Ahmedabad 380001 
Type of Sponsor  Government medical college 
 
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 
Dr Rajneesh Pathak  Govt Akhandanand Ayurved College and Hospital & Maniben Ayurved Hospital  Room No.9 Department of Kayachikitsa GOVT Akhandanand Ayurved College and Hospital Ahmedabad 380001 Gujarat & Room No.23 Department of Kayachikitsa Post Graduate division Maniben Ayurved Hospital Asarava Ahmedabad
Ahmadabad
GUJARAT 		 08866244063

drrajneeshpathak5sept@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,GOVT AKHANDANAND AYURVED COLLEGE,AHMEDABAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E782||Mixed hyperlipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP A - LEKHANIYA MAHAKASHAYA GHAN VATI   DOSE-6 Ghan vati(500mg each) two times a day before meal i.e. 6gm per day. ANUPAN - lukewarm water. DURATION- 6 weeks  
Comparator Agent  GROUP B- MUSTADI GHAN VATI   DOSE- 6 ghan vati(500mg each tab) two times a day before meal i.e. 6gm per day. ANUPAN-Lukewarm water. DURATION- 6 weeks.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.If any one or many parameters among lipid profile of an individual found to be in limit stated below,then the subject will be included in the study for objective criteria:
Serum cholesterol - 200mg/dl or more Serum triglycerides -150mg/dl or more
Serum LDL - 100mg/dl or more
Serum VLDL-10-30mg/dl or more
Serum HDL - <40mg/dl.
2.Patient’s ongoing anti-hyperlipidemic drugs will be stopped and wash out period will be specified.
3.The main signs and symptoms in the present study will be taken for subjective criteria are as follows-
weakness, Fatigue, Paraesthesia, Weight gain,
Angachalatva, Alasya, Kshudrashwas, Nidradhikya, Swedadhikya, Daurgandhya ,
Snigdhata, Atipipasa, Atikshudha, Angagaurava.
 
 
ExclusionCriteria 
Details  •Patient having age <18 or >60 yrs.
•Patient having serious cardiac problems- M.I., Cardiac Failure.
•Endocrinal disorders will not be taken for study like diabetes mellitus, hypothyroid.
•Patient having history of obesity and Hyperlipidemia due to drugs e.g. corticosteroids, Antidepressent drugs will not be taken for study.
•If Lipid profile parameters will come in “very high range, patient will be excluded which is given below-
Serum cholesterol- >300mg/dl.
Serum triglycerides- >500mg/dl.
Serum LDL ->190mg/dl.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
After completion of the course of the treatment the result will be assessed on the basis of - lipid profile of patients before and after treatment and difference in the score of sign and symptoms of Medoroga and dyslipidemia.  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2016 
Date of Study Completion (India) 05/04/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 published in INTERNATIONAL AYURVEDIC MEDICAL JOURNAL, VOLUME 10, ISSUE 04, APRIL 2022 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomised, Participant blinded, parallel group, active controlled trial to compare the efficacy of  Lekhaniya mahakashaya ghan vati in dose of 6 tablets twice of day with vehicle lukewarm water for 6 weeks in 15 patients of Dyslipidemia and Mustadi ghan vati in dose of 6 tablets twice of day with vehicle lukewarm water for 6 weeks in 15 patients of Dyslipidemia.   
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