| CTRI Number |
CTRI/2026/02/104291 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Navachara Chooranam in the management of Kalladaippu(Urolithiasis) |
|
Scientific Title of Study
|
A Prospective Open Labelled, Single Arm, Non- Randomized, Single Centric, Phase II Clinical Trial to determine the effectiveness of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS) |
| 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 M TAMIZHL ROSA |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7092738241 |
| Fax |
|
| Email |
tamizhlrosa27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P SATHISH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S JUSTUS ANTONY |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,PALAYAMKOTTAI. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002,Tamilnadu, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Tamizhl rosa |
Government Siddha Medical College and Hospital |
Department of Pothu Maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai ,Tirunelveli 627002
Tirunelveli
TAMIL NADU |
7092738241
tamizhlrosa27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE[2024-2025], GOVERNMENT SIDDHA MEDICAL COLLEGE & HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI 627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Navachara Chooranam |
Dosage-500 mg with water - After food-Twice a day
Duration - 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Evidence of renal calculus confirmed by USG
2.Renal colicky pain (loin to groin pain)
3.Nausea, vomiting, sweating
4.Haematuria
5.Dysuria
6.Patients who are willing to undergo radiological investigation and give blood for laboratory investigation. |
|
| ExclusionCriteria |
| Details |
1.Chronic Appendicitis
2.Pregnancy and Lactation
3.Pyelonephritis
4.Staghorn stones
5.Chronic Kidney Disease
6.Pelvic Inflammatory Disease
7.Diabetes Mellitus
8.Metabolic disorders like Hyperthyroidism, Hypothyroidism,Hyperparathyroidism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome aims to reduce the symptoms of Kalladaippu (urolithiasis) and to ensure that the kidney stone is expelled, disintegrated, or dissolved and mixed with urine. It also aims to determine the therapeutic efficacy of the clinical trial drug (Navachara Chooranam). |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The reduction in the size of kidney stones in USG abdomen and pelvis |
45 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)
|
25/03/2026 |
| 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="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
|
This study is A Prospective, Open-Labelled, Single-Arm, Non - Randomized, Single-Centric, Phase II Clinical Trial conducted to determine the effectiveness of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS). After proper purification, the trial drug is prepared and administered at a dose of 500 mg with water as an adjuvant for a period of 45 days. A total of 40 diagnosed Urolithiasis patients, including 20 outpatients (OP) and 20 inpatients (IP), are enrolled in the study. The primary outcome of the study is to evaluate the therapeutic efficacy of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS). The secondary outcome is to assess the reduction in the size of kidney stones as evidenced by USG abdomen and pelvis findings before and after the trail period. |