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CTRI Number  CTRI/2025/04/084245 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 07/04/2025
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 siddha medicine Seenthil choornam for Urinary Tract Infection 
Scientific Title of Study   A Single Arm Phase II Clinical Study To Evaluate The Effectiveness Of Siddha Formulation SEENTHIL CHOORNAM In The Treatment of NEERCHURUKKU (Urinary Tract Infection) Among Outpatients Attending Ayothidoss Pandithar Hospital, National Institute of Siddha. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha S 
Designation  Pg Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  6382721141  
Fax    
Email  meghadijo1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
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 S Megha  Ayothidoss Pandithar Hospital  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU 
6382721141

meghadijo1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF SIDDHA, CHENNAI-47  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable  
Intervention  Seenthil choornam  Seenthil choornam 2gms with ghee twice a day for 21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:
Age: 18 - 60 years.
Gender: All
Participants with positive urine culture at the beginning of screening.
Participants with urine pus cells more than 6 will be subjected to urine culture.
Uncomplicated UTI ( Infection of the urinary bladder (cystitis) with no known
relevant functional or anatomical urological abnormalities)
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome is assessed by reduction in colonies count and negative report of
urine culture test after a week of treatment. 
Primary Outcome is assessed by reduction in colonies count and negative report of
urine culture test after a week of treatment.(28 th day)  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in clinical signs and symptoms which can be assessed by UTI Symptom assessment
score (UTISA)  
Secondary outcome is assessed by after a week of treatment (28 th day)  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/04/2025 
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="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 - NO
Brief Summary  

Background:

The siddha system is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. Yugi classified diseases based on signs and symptoms. In his text book of Yugi vaithiya chinthamani, he classified neerchurukku into four types. One among them is Azhal Neerchurukku. Its signs and symptoms may be correlated with the Urinary Tract Infection in modern medicine.The characteristic features of Azhal Neerchurukku is Urine that may appear cloudy, dark and concentrated, oliguria, Suprapubic pain and pain in the urethra during and after voiding , Abrupt onset of frequency of micturation and urgency.

Urinary tract infections are the most common bacterial infections and affect one million people globally each year. Among nosocomial infections, Urinary tract infections are second only to lower respiratory tract infections, which represent twenty four percentage of such cases in developing countries. The symptoms of urinary tract infections are variable, ranging from no symptoms to a severely unwell patient with a high temperature and, sometimes, secondary bacteremia. Urinary tract infections can be divided into three catogories: acute pyelonephritis, acute cystitis, and asymptomatic bacteriuria. Clinically, Urinary tract infections is categorized as uncomplicated or complicated. Uncomplicated Urinary tract infections typically affect individuals who are otherwise healthy and have no structural or neurological urinary tract abnormalities. These infections are differentiated into lower urinary tract infections  and upper urinary tract infections . Urinary tract infections are caused by both Gram-negative and Gram-positive bacteria, as well as by certain fungi. The most common causative agent for both uncomplicated and complicated Urinary tract infections is uropathogenic Escherichia coli .

Objective:

Primary objective:

To determine the clinical effectiveness of the Siddha formulation Seenthil choornam in the management of Neerchurukku through urine culture.

Secondary objective:

The reduction in clinical signs and symptoms is assessed by urinary tract infection symptom assessment score UTISA questionarre.

Study design:

Study type : An experimental study

Study design : Single arm Phase II clinical study

Study place : Maruthuvam OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium,Chennai.

Study period : Eighteen Months

Sample size : Thirty

Inclusion criteria:

Age: Eighteen to Sixty years.

Gender: All

Participants with positive urine culture at the beginning of screening.

Participants with urine pus cells more than six will be subjected to urine culture.

Uncomplicated urinary tract infections -known relevant functional or anatomical urological abnormalities.

Exclusion criteria:

Complicated Urinary tract infections - Patients with relevant anatomical or functional abnormalities of the urinary tract, indwelling urinary catheters or with altered defences.

Known case of Renal CA

Known case of Renal Calculus

Known case of Medical Renal Disease

Known case of Genitourinary tuberculosis

Known case of Sexually transmitted diseases

Outcome:

Primary Outcome:

Primary Outcome is assessed by reduction in colonies count and negative report of urine culture test after a week of treatment.

Secondary Outcome:

Reduction in clinical signs and symptoms which can be assessed by Urinary tract infections Symptom assessment score as follows,

If the score is less than or equal to twenty one then it is severe.

If the score is less than or equal to fourteen then it is moderate .

If the symptom score becomes less than seven then it is considered as good improvement.

Results and discussion: The results will be statistically analyzed and reported.

Keywords: Neerchurukku, Urinary tract infection, Seenthil choornam.

 
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