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CTRI Number  CTRI/2021/12/038818 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 22/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda
Diagnostic
Screening 
Study Design  Other 
Public Title of Study   Difference between kulatta gutika with atrovastatin in the treatment of dislipidemia  
Scientific Title of Study   Comparative Evaluation of Efficacy of Kulattha Gutika with Atorvastatin in the Management of Dyslipidemia (Medoroga) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen Nandal 
Designation  pg scholar 
Affiliation  datta meghe institute of medical science 
Address  room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9813075320  
Fax    
Email  praveennandal320@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sadhana Misar wajpeyi 
Designation  Professor 
Affiliation  datta meghe institute of medical sciences 
Address  room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9763732083  
Fax    
Email  sadhanamisar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sadhana Misar wajpeyi 
Designation  Professor 
Affiliation  datta meghe institute of medical sciences 
Address  room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha

MAHARASHTRA
442001
India 
Phone  9763732083  
Fax    
Email  sadhanamisar@gmail.com  
 
Source of Monetary or Material Support  
Mahatma gandhi ayurved college hospital and research center 
 
Primary Sponsor  
Name  Mahatma gandhi ayurved college hospital and research center 
Address  salod hirapur wardha 
Type of Sponsor  Research institution and hospital 
 
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 Praveen Nandal  Mahatma gandhi ayurved college hospital and research center  Room no 30 department kayachikista Mahatma gandhi ayurved college hospital and research center
Wardha
MAHARASHTRA 
9813075320

praveennandal320@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma gandhi ayurved college hospital and research center institutional ethics committee salod wardha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kulttha gutika, Reference: bhavparkash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information:
2Comparator Arm (Non Ayurveda)-Atrovastatin10 mg HS for 45 days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study
Age between 30 to 60 years of either sex
Subjects fulfilling the following diagnostic criteria of Dyslipidemia

Diagnostic Criteria Serum Total Cholesterol less than or equal to 200 mg per dl and or
Serum Triglycerides equal to 150 to 499 mg per dl and or Serum HDL Cholesterol less than 40 mg per dl and or Serum LDL Cholesterol equal to 130 to 189 mg per dl  
 
ExclusionCriteria 
Details  Pre diagnosed cases of major illness like cardiovascular disorder diabetes mellitus and renal disorders
Patients taking the medication like glucocorticoids

During pregnancy and lactation period in women

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess efficacy of Kulattha Gutika in Total cholesterol Triglyceride HDL LDL VLDL and BMI  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of dyslipidemia as per prakruti corelation with medo roga  before treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/01/2022 
Date of Study Completion (India) 01/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per comport generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. 

The trial is a parallel-group, randomized, single-blind, standard - controlled trial. It will include, a 45 days treatment period, and a 15th, 30th 45th day week follow-up period.

 
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