CTRI/2024/06/069480
Not yet recruiting
Phase 2
A Comparative, randomized clinical trial to evaluate the efficacy & safety of Ural-BPH Capsule inadult patients with uncomplicated benign prostatic hyperplasia. - NI
Vasu Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vasu Healthcare Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male participants aged between 40 to 80 years diagnosed with symptomatic BPH and coexisting overactive bladder symptoms (OABS), with an IPSS greater than 8, who are treatment\-naive and do not wish to undergo surgery;2\.Symptomatic participants of BPH (determined by IPSS/focused urological exam/Investigations) associated with any one or more of the following overactive bladder symptoms like; micturition frequency of greater than 8 per 24 hrs, nocturia episodes of greater than 2 per 24 hrs., urgency episodes of greater than 1 per 24 hrs with or without urge incontinence;3\.Participants should be willing and able to complete a 4\-day voiding diary (before each visit i.e., on baseline, week 2, week 4, 8, 12 and 16\) and questionnaires.
Exclusion Criteria
- •1\.Age below 40 and above 80 years at the time of screening;
- •2\.Participant not willing for consent for inclusion in the above study and those who cannot comply with the study protocol due to concomitant CVA, CRF, vesical stones, untreated UTI, diabetic neuropathy, uncontrolled hypertension (BP greater than 180/100\), neurological disease etc.;
- •3\.Participants of BPH with absolute indications for surgery;
- •4\.Participants with contraindication, hypersensitivity and allergic reaction to components of investigational product and or tamsulosin hydrochloride;
- •5\.Participants with prior history of prostatic/urethral surgery, acute or chronic prostatitis, known prostate cancer, suspected neurogenic bladder, urethral stricture and priapism;
- •6\.Any other clinical condition which may jeopardize the study outcome or participant health in any way as per discretion of investigator.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A randomized, comparative clinical trial to evaluate the safety and efficacy of the vaginal cleaning effect of plasma-activated water using a plasma vaginal irrigator(WOMEN CARE®) in female patients with suspected vaginitisKCT0007202Roen Medical Center94
Not yet recruiting
Phase 1
A clinical study to compare effect of madhughrita pratisaran with calcium dobesilate in management of raktarsha(bleeding piles)Health Condition 1: K648- Other hemorrhoidsCTRI/2020/05/025259PDEA college of ayurved research centre
Not yet recruiting
Phase 3
Effect of viddha karma with agnikarma in the treatment of katigraha (back pain)CTRI/2023/10/059273PDEAS College of Ayurved and Research Centre,Nigdi,Pune
Recruiting
Phase 2
Role of ayurvedic therapeutics in the management of Diabetic macular edema (DME).Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complicationsCTRI/2021/05/033428ational Institute of Ayurveda
Not yet recruiting
Not Applicable
A clinical study to see the effect of Trivrttaashtaka Churna and Trivtt Churna as a therapeutic purgative in heathly individuals.CTRI/2019/10/021614Dr Mahesh Parappagoudra