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CTRI Number  CTRI/2024/02/062741 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Difference between Patoladigana Vasti versus standard control Triphala Kwath Lekhan Vasti in the management of Dyslipidemia Medoroga  
Scientific Title of Study   Evaluation of Comparative Efficacy of Patoladi Vasti versus Triphala Kwath Lekhan Vasti in the Management of Medoroga (Dyslipidemia) : A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Dhok 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha 
Address  Room No 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha
Telecom nagar Sevagram road near vaishanvi complex Wardha
Wardha
MAHARASHTRA
442001
India 
Phone  8788267996  
Fax    
Email  shrutidhok12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr shweta parwe 
Designation  professor hod 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha 
Address  Room No 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9403142270  
Fax    
Email  shweta.parwe@dmimsu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Dhok 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha 
Address  Room No 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8788267996  
Fax    
Email  shrutidhok12@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha 
Address  Room No 40 Department of Panchakarma Mahatma Gandhi Ayurveda 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 Shruti Dhok  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha  Room No 40 Department of Panchkarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha
Wardha
MAHARASHTRA 		 8788267996

shrutidhok12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe institute of Higher Education, Mahatma Gandhi Ayurved College Hospital and Research centre salod , Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः (Procedure Reference: ashtang Hridaya, Procedure details: making a triphala kwath lekhan basti 240ml & addministreted to a patient)
(1) Medicine Name: triphala kwath, Reference: ashtang Hridaya, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 240(ml), Frequency: od, Duration: 16 Days
2Intervention ArmProcedure-AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः (Procedure Reference: Ashtang Hridaya, Procedure details: making a kwath of patoladi gana basti 240ml & addministreted to a patient)
(1) Medicine Name: patoladi gana , Reference: ashtang Hridaya, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 240(ml), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Newly Diagnosed Dyslipedemia Patients with Serum Cholesterol > 20 mg/dl
Serum Triglycerides > 150 mg/dl
Serum HDL > 40 mg/dl
Serum VLDL > 30 mg/dl
Patient with Controlled Hypertension
Patient with Controlled type II Diabetes 
 
ExclusionCriteria 
Details  Patients with age < 20 years and > 60 years
Serum Triglycerides > 150 mg/dl
Serum HDL < 40 mg/dl
Serum VLDL < 30 mg/dl 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to asses the efficacy of Patoladi Vasti in Serum total Cholesterol level Triglycerides LDL HDL VLDL  7 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to asses the efficacy of triphala kwath lekhan Vasti in Serum total Cholesterol level Triglycerides LDL HDL VLDL  1 week 7th week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/02/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 the study protocol. willing 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 taken from IEC,MGACHRC, salod hirapur wardha and CTRI registration will be done. after selection , each participant will be tested individually and selected according to selection criteria. They are divided Inyo two group trial is parallel group, randomise, single blind standard control trail . it will include 16 days treatment period and at 48 day follow up period. 
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