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CTRI Number  CTRI/2026/02/102786 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial on Thirikandagathi kiyaazham in the treatment of Kalladaippu among patients attending OPD, Government Siddha Medical College, Palayamkottai 
Scientific Title of Study   A CASE SERIES ON ASSESSMENT OF EFFECTIVENESS OF THIRIKANDAGATHI KIYAAZHAM IN THE TREATMENT OF KALLADAIPPU (UROLITHIASIS) AMONG PATIENTS ATTENDING OPD, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KANTHA MEENA P 
Designation  PG scholar 
Affiliation  Government Siddha Medical College and Hospital, Palayamkottai  
Address  OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India.

Tirunelveli
TAMIL NADU
627002
India 
Phone  8300511355  
Fax    
Email  kpmeena2511@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Subash Chandran 
Designation  Associate professor 
Affiliation  Government Siddha Medical College and Hospital 
Address  PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvanathapuram main road, Palayamkottai, Tirunelveli.

Tirunelveli
TAMIL NADU
627002
India 
Phone  9345600723  
Fax    
Email  siddhadrgs21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S JUSTUS ANTONY 
Designation  Head of the Department 
Affiliation  Government Siddha Medical College and Hospital 
Address  PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli.

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443090849  
Fax    
Email  justusantony71@gmail.com  
 
Source of Monetary or Material Support  
OPD,IPD Facilities and Central library of Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli-627002, Tamil Nadu, India 
 
Primary Sponsor  
Name  Government Siddha Medical College and Hospital 
Address  Government Siddha Medical College and Hospital, Tiruvanathapuram main road, Palayamkottai, Tirunelveli TAMIL NADU,India 
Type of Sponsor  Government medical college 
 
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 KANTHA MEENA P  Government Siddha Medical College and Hospital  OP number 10,PG Department of Pothu Maruthuvam,Tiruvananthapuram main road, Palayamkottai.
Tirunelveli
TAMIL NADU 		 08300511355

kpmeena2511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (2024-2027)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N20||Calculus of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Thirikandagathi kiyaazham   DOSAGE:50ml Twice a day orally for 40 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Size of the renal stone-less than 10mm confirmed by USG
Renal colicky pain (loin to groin pain)
Oliguria
Dysuria
Haematuria
Nausea and vomiting
 
 
ExclusionCriteria 
Details  Chronic kidney disease
Pelvic inflammatory disease
Pyelonephritis
Appendicitis
Associated with Metabolic disorders
Pregnancy& lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome will be aimed at reducing the
symptoms of Kalladaippu-Urolithiasis and the kidney stone is expelled to come out or be disintegrated and mixed with urine will be ensured and to
determine the therapeutic efficacy of clinical trial
drug(Thirikandagathi kiyaazham) 		 40 days 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be aimed at reducing the size of the kidney stone in USG Abdomen and pelvis  40 days
 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   02/03/2026 
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="4"
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   This is a Prospective Open labelled single arm non randomized single centric phase II clinical trial to determine the effectiveness of Thirikandagathi kiyaazham in the management of Kalladaippu (Urolithiasis). After purification of trial drug, Kudineer chooranam formulation is prepared and administered at the dosage of 50 ml with honey for 40 days, which is given to 20 known urolithiasis patients.  The primary outcome will be aimed to determine the therapeutic efficacy of Thirikandagathi kiyaazham in the treatment of Kalladaippu(Urolithiasis). The secondary outcome will be aimed at reducing the clinical symptoms and the size of the Kidney stone.  
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