Double Blind Controlled Trial In Benign Prostatic Hyperplasia Using Individualized Homoeopathic Medicine And Homoeopathic Dilution Of Conium Maculatum - A Two Arm Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Changes in Prostatic Volume (PV) in Ultrasound scan
Study Overview
Brief Summary
This study is a Double Blind Controlled Trial in Benign Prostatic Hyperplasia using Individualized Homoeopathic Medicine and Homoeopathic Dilution of Conium maculatum - a two arm Randomized Controlled Trial, that will be conducted in the Outpatient and Inpatient departments, Peripheral centers and Camps conducted under the Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measure will be, the changes in Prostatic Volume (PV) in Ultrasound scan which will be measured every 5 months (at Baseline, 5th month and at the end of the study). The secondary outcomes will be, changes in Post Void Residual Urine (PVRU) Volume in Ultrasound scan measured at Baseline, 5th month and at the end of the study and Changes in International Prostate Symptom Score (IPSS) measured every month from baseline to the end of the study. Since there hasn’t been any studies conducted solely to explore the effectiveness of Conium maculatum in Benign Prostatic Hyperplasia cases, conducting a double blind randomized controlled trial, may help in unveiling and exploring more therapeutic actions of Conium in this regard.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.Male patients within the age group 40 to 80 years 2.Cases with positive ultrasound findings of BPH.
Exclusion Criteria
- •1.Chronic prostatitis/Prostate abscess/Ca prostate/ History of any malignancies 2.PSA greater than 4 ng/mL 3.Other cases of Urinary retention greater than 24hrs/ Recurrent gross hematuria/Bladder stone/ Recurrent UTI/Urethral stricture.
- •4.Known cases of serious systemic illnesses like Uncontrolled Diabetes Mellitus, Malignancies, Malignant Hypertension, Severe cardiac diseases 5.Cases that are under other medications for BPH.
Outcomes
Primary Outcomes
Changes in Prostatic Volume (PV) in Ultrasound scan
Time Frame: Baseline, 5th month and at the end of the study
Secondary Outcomes
- 1.Changes in Post Void Residual Urine (PVRU) Volume in Ultrasound scan(2.Changes in International Prostate Symptom Score (IPSS))
Investigators
Dr Gouri Krishnan H
National Homoeopathy Research Institute In Mental Health