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CTRI Number  CTRI/2024/06/069490 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A study on Vengara chunnam for urolithiasis patients 
Scientific Title of Study   Single centric non-randomized open clinical trial phase II in Vatha kalladaippu (Urolithiasis) with siddha medicine Vengara chunnam 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  Saranya N 
Designation  Pg scholar 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106,Tamilnadu.

Chennai
TAMIL NADU
600106
India 
Phone  9342168987  
Fax    
Email  saranyajothi1211@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R MENAKA 
Designation  Lecturer 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106,Tamilnadu.

Chennai
TAMIL NADU
600106
India 
Phone  9444669661  
Fax    
Email  rangasamymenaka75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R MENAKA 
Designation  Lecturer 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106,Tamilnadu.

Chennai
TAMIL NADU
600106
India 
Phone  9444669661  
Fax    
Email  rangasamymenaka75@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, No:6, Anna Arch Road, Arumbakkam, Chennai 600106. 
 
Primary Sponsor  
Name  NSaranya  
Address  Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam Chennai-600106, Tamil Nadu, India. 
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 
DrN Saranya  Government Siddha Medical College, Chennai.  Department of PG Pothu Maruthuvam, Room No S1, Government Siddha Medical College Hospital, Arumbakkam, Chennai - 600106.
Chennai
TAMIL NADU 		 9342168987

saranyajothi1211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Arumbakkam, Chennai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N209||Urinary calculus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Vengara Chunnam  The medicine will be given 200mgs twice a day with Adjuvant Neermulli Kudineer after food for 48 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.All gender
2.Age 18-60 years
3.Lower Abdominal pain
4.Flank pain
5.Burning Micturition
6.Oliguria
7.Haematuria
8.Presence of calculi of size 4-9mm. 
 
ExclusionCriteria 
Details  1.Stag horn calculus
2.Hydronephrosis
3.Cancer
4.Chronic kidney disease
5.Pregnancy
6.Lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in clinical symptoms such as lower abdominal pain,oliguria,dysuria.  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in size of the stone  90 days 
 
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 (Others) -  Nil

  6. For how long will this data be available start date provided 05-06-2025 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   Urolithiasis is recurrent renal disease affecting 12% population in India. Urinary calculi consist of  aggregates of crystals,usually containing calcium or phosphate in combination with small amount of proteins and glycoproteins.The most common types are calcium oxalate 60%,calcium phosphate 15%,struvite 15%,uric acid 10%,cysteine and others 1%.The predisposing factors are low urine volume,high ambient temperature,low fluid intake,high protein,high sodium excretion,high oxalate excretion,low citrate excretion,hypercalcemia of any cause.Renal stones vary greatly in size from sand like particles anywhere in the urinary tract to large round stones in the urinary bladder. In siddha system of medicine, there are unique combination of medicines that have solution to renal calculi. One such combination is VENGARA CHUNNAM which will be more effective and reliable. The method of preparation of medicine is easy and the raw drugs are also easily available. 
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