Randomized controlled trial and assessment of antimicrobial effect of Gokshur kwath and Yavakshar in mootrakrichchhra with special reference to recurrent urinary tract infections.
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Department of Shalya Tantra Faculty of Ayurveda Insitute of Medical Sciences
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement in symptoms like-
Overview
Brief Summary
Conventional antibiotics are the first choice in an acute episode of UTI; therefore, resistance of pathogenic bacteria to antibiotics is of high clinical concern. The concept of the control of drug resistance is rather widely held today. Therefore the world looks at some alternative and effective medicine particularly of natural origin. In Ayurvedic texts various acharyas mentioned the shodhana and Shaman chikitsa for it. The Gokshurkwath and Yavakshar are mentioned as mootrakrichchhrahara in Bhashajya Ratnavali. Hence, the present study aims to explore the efficacy of therapeutic and antimicrobial effect of Gokshurkwatha and Yavakshar in the management of mootrakrichchhra with special reference to recurrent Urinary tract infections.
60 cases of mootrakrichhra will be included in this interventional study which will be randomly divided into 2 groups of 30 patients in each group. One group will be prescribed gokshura kwath 40ml and yavakshar 500 mg BD for 30 days .Second group will be prescribed nitrofurantoin 100mg TDS for 15 days after doing urine culture and sesitivity .The study will be conducted for 60 days with 4 follow up after every 15 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult male and female subjects of age 18-60 yrs having symptoms of Mootrakrichchhra such as Bastishul (pain in lower abdomen)/Muhurmuhurmootrata(frequent micturition)/ Sadaahmootrata (burning micturition)/Krichchhrapravrutti of Mootravahana/ Sarujamootrata (painful micturition/dysuria)and with positive urine culture and sensitive to nitrofurantoin.
- •Patients having symptoms of recurrent Urinary tract infections i.e. 3 or more culture proven infections within a 12 months period, or as 2 or more culture proven infections in a 6 months period Subjects willing to sign informed consent and follow the study procedure.
Exclusion Criteria
- •Subjects having symptoms of mootraghat such as vibandh of mootra (obstructive flow of urine, saraktmootrata (gross hematuria), mootrasang (stricture of urethra)vatashthila (enlarged prostate).
- •Subjects of age group less than 18 years and more than 60 years.
- •Complicated Urinary tract infections like Catheterization, anatomic and functional abnormalities, immune suppression, renal disease, renal calculi, pyelonephritis, neurogenic bladder) History of interstitial cystitis,bph,Urothelial cancer Pregnancy STDs ,Tuberculosis affecting the bladder.
- •HIV, Anti-HCV &, HBsAg positive subjects.
- •Patient suffering from any other systemic diseases Uncontrolled Hypertension Uncontrolled Diabetes mellitus T.B Malignancy Patients with sterile urine specimen.
Outcomes
Primary Outcomes
Improvement in symptoms like-
Time Frame: 2 months
Bastishul (pain in lower abdomen)
Time Frame: 2 months
Muhurmuhurmootrata(frequent micturition)
Time Frame: 2 months
Sadaahmootrata (burning micturition) Krichchhrapravrutti of Mootravahana/ Sarujamootrata (painful micturition/dysuria)
Time Frame: 2 months
Secondary Outcomes
- To study the antimicrobial effect of Gokshur Kwath and Yavakshar(2 months)
Investigators
Smita Pandey
BHU