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CTRI Number  CTRI/2024/09/073351 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   Clinical Evaluation of Siddha Medicine PIRANDAI VADAGAM for Deepana Silathuma Noi (Disorder in lipid profile) (DYSLIPIDEMIA)  
Scientific Title of Study   SINGLE CENTRIC NON RANDOMIZED OPEN CLINICAL TRIAL PHASE II IN DEEPANA SILATHUMA NOI (DYSLIPIDEMIA) WITH SIDDHA MEDICINE PIRANDAI VADAGAM AMONG PATIENTS ATTENDING OPD AT GOVERNMENT SIDDHA MEDICAL COLLEGE HOSPITAL CHENNAI 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhildhar T 
Designation  PG scholar  
Affiliation  Government Siddha Medical College  
Address  Room no S1,Government Siddha Medical College,Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9790549422  
Fax    
Email  dhilu3010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Anbu 
Designation  Professor and head of the department  
Affiliation  Government Siddha Medical College  
Address  Room no S1,Government Siddha Medical College,Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N Anbu 
Designation  Professor and head of the department  
Affiliation  Government Siddha Medical College  
Address  Room no S1,Government Siddha Medical College,Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Source of Monetary or Material Support  
Govt. Siddha Medical College, Arumbakkam, Chennai - 600 106  
 
Primary Sponsor  
Name  Dhildhar T 
Address  Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai 
Type of Sponsor  Other [Self] 
 
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 T Dhildhar   Government Siddha Medical College and hospital   Department of PG Pothu maruthuvam, Room no S1, Arumbakkam, Chennai - 600 106. Chennai TAMIL NADU
Chennai
TAMIL NADU 		 9790549422

dhilu3010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Government Siddha Medical College Arumbakkam Chennai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E784||Other hyperlipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Pirandai Vadagam   500 mg, tds after food with hot water for 3 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who have derangement in lipid profile  
 
ExclusionCriteria 
Details  Patients who have history of pancreatitis, hypothyroidism, IHD, Stroke. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Normal in lipid profile assessed by blood investigation.  The outcome will be assessed with in 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Normal in BMI will be assessed as secondary outcome.  Outcome may be expected in a period 12 weeks
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/09/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhilu3010@gmail.com].

  6. For how long will this data be available start date provided 02-06-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Dyslipidemia is a very common lifestyle disorder.Dyslipidemia can have a number of clinical consequences, most notably premature atherosclerotic cardiovascular disease (ASCVD), and therefore important to appropriately diagnose and treat. In the siddha system of medicine Dyslipidemia is treated with a unique combination of medicine PIRANDAI VADAGAM which will be cost effective and reliable.The aim of this study is the management Deepana Silathuma Noi (Dyslipidemia)  with the Siddha medicine PIRANDAI VADAGAM  and the objective is to determine the therapeutic efficacy and safety profile of the Siddha medicine PIRANDAI VADAGAM in the treatment of Deepana Silathuma Noi (Dyslipidemia). As the literary evidences support the usage of drugs in the disease, hypothesis is created in such a way that the efficacy of PIRANDAI VADAGAM will be a better solution for the management of Deepana Silathuma Noi (Dyslipidemia) 
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