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Clinical Trials/CTRI/2026/02/102786
CTRI/2026/02/102786
Not yet recruiting
Phase 2

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

Government Siddha Medical College and Hospital1 site in 1 country20 target enrollmentStarted: March 2, 2026Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Government Siddha Medical College and Hospital
Enrollment
20
Locations
1
Primary Endpoint
The outcome will be aimed at reducing the

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Size of the renal stone-less than 10mm confirmed by USG Renal colicky pain (loin to groin pain) Oliguria Dysuria Haematuria Nausea and vomiting.

Exclusion Criteria

  • Chronic kidney disease Pelvic inflammatory disease Pyelonephritis Appendicitis Associated with Metabolic disorders Pregnancy& lactating women.

Outcomes

Primary Outcomes

The outcome will be aimed at reducing the

Time Frame: 40 days

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

Time Frame: 40 days

determine the therapeutic efficacy of clinical trial

Time Frame: 40 days

drug(Thirikandagathi kiyaazham)

Time Frame: 40 days

Secondary Outcomes

  • The secondary outcome will be aimed at reducing the size of the kidney stone in USG Abdomen and pelvis(40 days)

Investigators

Sponsor
Government Siddha Medical College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

KANTHA MEENA P

Government Siddha Medical College and Hospital, Palayamkottai

Study Sites (1)

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