A clinical study to compare the effect of two drugs - patala kshara in tilataila and trikantakadi guggulu in patients with Benign Prostatic Hyperplasia.
Phase 3
Not yet recruiting
- Conditions
- Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,
- Registration Number
- CTRI/2024/02/062595
- Lead Sponsor
- Dr Subi N H
- Brief Summary
This study is a non randomized active controlled trial comparing the effectiveness of Patala kshara 500mg along with tilataila 5ml twice daily and Trikantakadi guggulu two 500mg tablets twice daily for 60 days in 70 patients with Benign Prostatic Hyperplasia, that will be conducted at Govt. Ayurveda College Hospital, Tripunithura, Ernakulam, Kerala, India. The primary outcome measures will be International Prostate Symptom Score and Quality of Life, assessed on baseline, 31 and 61 days. The secondary outcomes will be Post-residual Urine Volume and Prostate Volume assessed by Transabdominal Ultrasound on baseline and after treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 70
Inclusion Criteria
- •Patients with LUTS secondary to BPH and diagnosed by Transabdominal Ultrasound.
- •BPH with IPSS score minimum 5.
- •Patients who are willing to provide written informed consent.
Exclusion Criteria
- •Known cases of Prostatitis, Carcinoma Prostate and those who have undergone any surgery for Prostate.
- •Known cases with complications of BPH like acute urinary retention, haematuria, hydronephrosis and renal insufficiency.
- •Known cases of stricture of urethra, congenital contracture of bladder neck and bladder polyps and diverticula.
- •BPH patients with severe cardiac disease, uncontrolled diabetes mellitus and immuno-compromised.
- •Those who are contraindicated for the internal use of kshara.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome– International Prostate Symptom Score (IPSS) and QOL will be assessed using At baseline, 31st day and 61st day. validated questionnaire to quantify the reduction in LUTS . At baseline, 31st day and 61st day.
- Secondary Outcome Measures
Name Time Method Change in Post-Void Residual urine volume (PVR) & Prostate Volume (PV) will be assessed using Transabdominal Ultrasound. At baseline & after 60 days
Trial Locations
- Locations (1)
Government Ayurveda College, Tripunithura
🇮🇳Ernakulam, KERALA, India
Government Ayurveda College, Tripunithura🇮🇳Ernakulam, KERALA, IndiaDr Subi N HPrincipal investigator9495881390drsubironish@gmail.com