A STUDY OF SAGALANOI CHOORANAM IN THE MANAGEMENT OF KALLADAIPPU (RENAL CALCULUS)

Phase 3

Not yet recruiting

• Conditions: Calculus of kidney,

• Registration Number: CTRI/2023/02/049695
• Lead Sponsor: National institute of siddha

Brief Summary

INTRODUCTION:This is an open clinical trial to evaluate the effectiveness of SAGALANOI CHOORANAM inthe management of RENAL CALCULI (Kalladaippu) through USG KUB before and aftertreatment Renal calculi occurs when solutes crystallize out of urine to form stones. Urolithiasismay occur due to anatomic features leading to urinary stasis, low urine volume, dietary factors(e.g., high oxalate or high sodium), urinary tract infections, systemic acidosis, medications.The most common cause of renal stone disease is inadequate hydration and subsequent lowurine volume. Researchers have concluded that about one in ten people will get a kidney stoneduring their lifetime.

OUTCOME: Assesment by clearance or reduction in the size of the renal calculi in USG ABDOMEN / KUB after treatment



MATERIALS AND METHODS:A total of 10 patients diagnosed with kalladaippu ( Renal calculi) who are adults willing toparticipate in the study by signing the consent form will be enrolled in the study . Patients withStone size > 9mm ,K/H/O Malignancy, Pregnant women and planning to be pregnant withinthree months, Lactating mother, K/H/O Chronic kidney disease, Uncontrolled systemic illnessand patients not willing to sign the consent form will be excluded from the study. Assessmentwill be done through USG Abdomen or CT KUB before and after the study



RESULTS AND DISCUSSION: The results will be statistically analysed



KEYWORDS: Kalladaippu, Renal calculi, Sagalanoi chooranam

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-13
• Study Start: 2023-02-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 1. Patient with renal calculus detected on USG Abdomen, Stone size: <9mm&≥4mm 2. Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion. 3. Patient who are willing to take Ultrasonography investigation (USG.
• Abdomen/ CT KUB) and provide blood sample for lab investigation.

Exclusion Criteria

• K/H/O Malignancy 2.
• Pregnant women and planning to be pregnant within three months 3.
• Lactating mother 4.
• K/H/O Chronic kidney disease 5.
• Uncontrolled systemic illness 6.
• K/C/O Ischemic heart disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assesment by clearance or reduction in the size of the renal calculi in USG	2MONTHS - SCREENING | 2MONTHS - PATIENT ENROLLMENT | 2MONTHS - OUTCOME ASSESSMENT
ABDOMEN / KUB after treatment	2MONTHS - SCREENING | 2MONTHS - PATIENT ENROLLMENT | 2MONTHS - OUTCOME ASSESSMENT

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr N A Bharathi

Principal investigator

8072549689

cadbury156@gmail.com