A clinical study of Individualized Homoeopathic treatment in the management of Benign Prostatic Hyperplasia using the International Prostate Symptom Score.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To ascertain the effectiveness of Individualized Homoeopathic medicines in cases of BPH and clinically assess the outcome by using IPSS, BII (BPH Impact Index) which is a Quality of Life index, every 15 days.
Study Overview
Brief Summary
This is a Non-randomized study to assess the effectiveness of Individualized Homoeopathic Medicines in the treatment of Benign Prostatic Hyperplasia (BPH) by using clinical assessment tools like the International Prostate Symptom Score (IPSS) and a QoL index known as the BPH Impact Index (BII) along with a Radiological investigation modality, USG Pelvis before and after the treatment to confirm the variation in the PVR volume post the 3-month treatment period.
30 patients will be enrolled into the study at BVDUHMC, Pune.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 40.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Patients who fulfill the case definition.
- •Patients aged 40 years and above will be included in the study.
- •Only symptomatic patients will be taken into the study.
- •Patients without any advanced systemic illnesses.
- •Patients willing to participate in the study and willing to sign the informed consent.
Exclusion Criteria
- •Patients with IPSS score of greater than 20 (severe BPH) requiring surgical intervention.
- •Patients with Hematuria will not be taken into the study.
- •Patients with Vesical Calculi (Urinary bladder stones).
- •Patients under any other medications for BPH.
Outcomes
Primary Outcomes
To ascertain the effectiveness of Individualized Homoeopathic medicines in cases of BPH and clinically assess the outcome by using IPSS, BII (BPH Impact Index) which is a Quality of Life index, every 15 days.
Time Frame: The patient will be followed up every 15 days and his IPSS score and BII scores will be recorded every 15 days to assess the effect of the given treatment and the progress of the condition.
Secondary Outcomes
- To assess the variation in Post-void Residual Volume (PVR volume) by USG pelvis before and after the treatment.(Every patient will be under Homoeopathic treatment for 3 months and USG Pelvis will be recorded before and after the 3 months of treatment to assess the variation in the PVR volume.)
Investigators
Sai Bhaskar D
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital