CLINICAL RESEARCH ON TRADITIONAL SIDDHA MEDICINE IN KALLADAIPPU (KIDNEY STONE)PATIENTS.
- Conditions
- KALLADAIPPU(KIDNEY STONE)
- Registration Number
- CTRI/2013/12/004203
- Lead Sponsor
- AYOTHIDOSS PANDITHAR HOSPITAL
- Brief Summary
It is a single, non-randomized, open-label trial to determine the efficacy and safety of NANDUKKAL PARPAM in patients with KALLADAIPPU (UROLITHIASIS). The trial drug Nandukall parpam is a sidhha medicine (Traditional Indian system of Medicine) developed from marine product named as fossil stone crab (Nandukkal).In this trial 110 kidney stone patients will be recruited and the trial drug will be administered 260 mg twice a day along with sirupeelai kudineer (a decoction made from whole plant of Aerva lanata) for a period of 60 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically . The out come of this trial will be published in Indian Journal of Medical Research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 110
- •Age between 20 and 60 years •Both male and female patients •Classical pain is described as pain from loin to groin, accompanied by nausea, vomiting and gaseous distension.
- •Pain and or burning while passing urine.
- •Patient with renal calculus detected on X-ray KUB or USG abdomen •History of Recurrence of renal stone •Stone size 5mm & > 5mm to < 10mm •Urine routine which will show Crystals in urine.
- •Patients are willing and able to give informed consent for participation in the study.
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Stone size > 10 mm •Obstruction requiring immediate surgery (Marked hydronephrosis) •Pregnancy and Lactation •women with childbearing potential without adequate contraception •Use of disallowed concomitant medications (NSAID) •Patient taking any other lithotriptic agent •History of Diabetes/ Hypertension •History of hepatic/ renal/ cardiac disease •History of taking treatment for any other ailments.
- •History of drug/alcohol abuse oExperiencing habitual alcohol-related legal problems.
- oRepeated drinking despite ongoing alcohol-related relationship problems.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- •Treatment with another investigational drug or other intervention (within a period of 30 days) •Participated in any research study within the past six months.
- •Donated blood within the past six months.
- •Any psychiatric condition that could prevent patient from signing the informed consent or could put the patient at an unacceptable risk in case of participating in the trial •Medical condition, laboratory finding, or physical exam finding (e.g., vital signs outside of specific range) that precludes participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method STONE EXPULSION,REDUCTION IN STONE SIZE AFTER 60 DAYS OF TREATMENT
- Secondary Outcome Measures
Name Time Method RENAL FUNCTION -UREA,CREATININE,URIC ACID LEVEL PRE STUDY SCREENING AND AFTER 60 DAYS OF TREATMENT
Trial Locations
- Locations (1)
AYOTHIDOSS PANDITHAR HOSPITAL
🇮🇳Kancheepuram, TAMIL NADU, India
AYOTHIDOSS PANDITHAR HOSPITAL🇮🇳Kancheepuram, TAMIL NADU, IndiaDRHNALINI SOFIAPrincipal investigator9677777677dr.h.nalinisofia@gmail.com