Cystone in kidney stones

Phase 3

Recruiting

• Conditions: urolithiasis

• Registration Number: CTRI/2012/01/002350
• Lead Sponsor: The Himalaya Drug

Brief Summary

Each Cystone Extract Route Tablet contains following herbs:

Gokshura, Punarnava, Pasanabheda, Kulattha and Varuna.

Each Cystone tabletcontains following herbs:

Shilapushpa, Pasanabheda, Manjishtha, Nagaramusta, Apamarga, Gojiha, Sahadevi, Hajrul yahood bhasma and Shilajeet (Purified). The subjects presenting with symptoms of Urolithiasis like colicky pain, hematuria, dysuria, retention of urine, decrease in frequency of urination and other symptoms of Urolithiasis will be screened by the investigator.The subjects will be randomly assigned to either investigational product group or comparator group and will be instructed to take Cystone Extract route Tablet or Cystone tablet twice daily for 3 months. Subject will undergo general physical examination, systemic examination and abdominal examination specifically for renal stones on all the visits. During baseline and end of study, urine routine, ultrasonography abdomen and pelvis will be performed. Assessment will be done, at each visit at the end of 1 month, 2 month and 3 month.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-10
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •Subject with Urolithiasis as disgnosed by clinically as well as ultrasonographically with calculi measuring more than 5 mm.
• •Hematologic and Biochemical parameters within normal limits.
• • Willing to sign inform consent document.

Exclusion Criteria

• •Those with serious cardiovascular, cerebrovascular, respiratory, liver or renal disease or any other disorder.
• •The subjects not to have used any drugs, for at least 1 week prior to the study.
• •Subjects with a strong history of food or drug allergy of any kind.
• •Subjects not to have been on weight reducing diets within 3 months prior to the start of the study.
• •Patients unwilling to provide informed consent or abide by the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptomatic relief from clinical symptoms of urolithiasis and reduction in the stone size by ultrasonography	3 months

Secondary Outcome Measures

Name	Time	Method
To assess the safety profile of Cystone Extract route tablet in Urolithiasis and overall compliance to the drug treatment.

Trial Locations

Locations (1)

Department of Surgery; 🇮🇳 Mandya, KARNATAKA, India

Department of Surgery

🇮🇳Mandya, KARNATAKA, India

Dr Narasimhaswamy M S

Principal investigator

drnarasimhaswamymandya@gmail.com