Efficacy of Pedalium murex On kidney stone

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012735
• Date of registration: 22-03-2018
• Prospective Registration: No
• Primary sponsor: Department of RESEARCH AND DEVELOPMENT
• Public title: Efficacy of Pedalium murex On kidney stone
• Scientific title: Efficacy of Pedalium murex L. on Urolithiasis
• Date of first enrolment: 31-10-2015
• Target sample size: 300
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12029
• Study type: Observational
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Kishor Kumar
• Affiliation: Sri Lakshmi Narayana Institute of Medical Sciences

• Name: Kishor Kumar
• Affiliation: Sri Lakshmi Narayana Institute of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Sex : either sex

Any three of the following signs and symptoms if present

1.Intermittent dull/ colicky pain

2.Haematuria

3.frequency of micturition

4.Burning micturition

Evidence of calculus as per diagnostic procedure.

a.X ray KUB region

b.USG abdomen

c.Cystoscopy

d.IVP




Exclusion criteria: 1.Age below 18 and above 60

2Staghorn Calculi

3.Hydronephrosis

4.Pyelonephritis

5.Diabetes mellitus

6.Malignancy

7.Chronic renal failure

8.UTI infection

Impaired renal function



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- pt with complaints within inclusion criteria

Primary Outcome(s)

the outcome of the study to explore whether the trial drug pedalium murex is safe and effective in reducing the size of the stones or effective in eliminating the stones.Timepoint: 48 DAYS

Secondary Outcome(s)

the outcome of the study to explore whether the trial drug pedalium murex is safe and effective in reducing the size of the stones or effective in eliminating the stones.Timepoint: 48 DAYS

scientific evidence of clinical trial drug ( Pedalium murex ) based on the scientific evidence and we will apply for patentTimepoint: 3 MONTHS

Secondary ID(s)

srikumar

Source(s) of Monetary Support

Bharath university , Chennai

Ethics review

Status: Approved
Approval date: 23/02/2015
Contact:

Institutional Human ethical committee