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CTRI Number  CTRI/2024/02/062434 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To access the efficacy of Amalkyadi Kaphaghna Basti with Lekhaghna Basti in the treatment of Dyslipidemia 
Scientific Title of Study   Evaluation of Comparative efficacy of Amalkyadi Kaphghna basti versus Lekhana basti in the management of Dyslipedemia Medoroga A Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shamli Hiware 
Designation  Assistant Professor Phd Scholar 
Affiliation  Datta Meghe Institute Of Medical Sciences 
Address  Room no 40 Department of panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7709793303  
Fax    
Email  shamlihiware57@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shamli Hiware 
Designation  Assistant Professor Phd Scholar 
Affiliation  Datta Meghe Institute Of Medical Sciences 
Address  Room no 40 Department of panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7709793303  
Fax    
Email  shamlihiware57@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Punam Sawarkar 
Designation  Associate Professor 
Affiliation  datta meghe institute of medical sciences wardha 
Address  Room no 40 Department of panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9860667023  
Fax    
Email  drsuple.punam@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College Hospital and Research Centre 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurved College Hospital and Research Centre 
Address  Department of panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod 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 Shamli Hiware  Mahatma Gandhi Ayurved College Hospital and Research Centre  Room no 40 Department of Panchakarma
Wardha
MAHARASHTRA 		 7709793303

shamlihiware57@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E66||Overweight and obesity. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushruta Samhita, Procedure details: Amalakyadigana in the form of Bastikarma for 15 days total 550 ml dose Before food)
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushruta Samhita, Procedure details: Ushakadigana in the form of Bastikarma for 15 Days Total 550 ml dose Before food)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are willing to give Written Informed Cosent
Clinical cases of Dyslipidemia as per 1CD 10 Criteria E78 point 5 diagnosed with either sex between the age group of 20 to 50 years
Diagnosed and confirmed cases of Dyslipidemia according to National Cholesterol Education Program and Adult Treatment Panel 3
NCEP ATPIII 2001 as follows
Total cholesterol less than or equal to 200 mg per dL and or
LDL from 130 to 189 mg per dL and or
Sr Triglycerides between 150 to 499 mg per dL and or
Sr HDL more than 40mg per dL

 
 
ExclusionCriteria 
Details  Patients who are not willing to give Written Informed Consent
Patients with Unstable Angina myocardial infarction stroke transient ischemic attack cardiovascular surgery or major operations within 6 months prior to screening visit
Patient having systemic illness like Tuberculosis Carcinoma Endocrine disorders and Renal or Liver disorder
Drug induced Dyslipidemia like steroids etc Pregnant Lactating women
Patients with Ano-rectal disorders like Fissure Fistula Haemorrhoids etc
Patients with Hypothyroidism
Patients with NIDDM
Patients with Hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To access the efficacy of Kaphaghna Basti in Lipid Profile  1 month 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To access the efficacy of Lekhana Basti in Lipid Profile  45 Days 
To access the efficacy of Tab Atrovastatin 10 mg in Lipid Profile  45 Days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3/ Phase 4 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/02/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   the Volunteers will be informed about protocol, welling participants will be randomly selected as per computer generated table. clinical research format will be prepared and validated. prior to the study approval will be taken from IEC and MGAC and RC Salod Hirapur Wardha. CTRI registration will be done after selection each participants will be tested individually and selected according to selection criteria. they are divided into 3 groups the trial is parallel group  randomized open table Standard Control trial. it will include 45 days treatment period and a follow up period on 15th, 30th, 45th day. 
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