Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With LUTS/BPH

Study Overview
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Brief Summary
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To evaluate efficacy and safety of garcinia extract + chromium combinations (Chromax) in symptomatic benign prostatic hypertrophy patients

Detailed Description
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Benign prostatic hypertrophy (BPH) can be defined as a slowly progressive prostatic adenoma that cause bladder outlet obstruction. Risk factors for BPH can be classified into modifiable risk factor including genetic factors and age with prevalence of 50% to 60% for males in their 60's up to 80% to 90% of those who are over 70 years of age, and non-modifiable risk factors including sex steroid hormones, the metabolic syndrome, obesity, diabetes, physical activity, diet, and inflammation. The clinical presentation of BPH can be categorized into storage and voiding abnormalities. Symptoms include urinary frequency and urgency, nocturia and dysuria in addition to urinary hesitancy, dribbling and incomplete bladder voiding. Several hypotheses are postulated to explain the pathophysiology of BPH including the testosterone and dihydrotestosterone, age related tissue remodelling, prostatic inflammation and metabolic aberration as obesity, diabetes and dyslipidemia. Oxidative stress has been reported to play a role the pathogenesis of BPH. Oxidative stress has been considered to be one of the mechanisms that trigger the chain of reactions involved in the development and progression of prostatic hyperplasia. This is especially true as the human prostate tissue is vulnerable to oxidative DNA damage due to more rapid cell turnover and fewer DNA repair enzymes. In a study conducted on prostate tissue, it was observed that oxidative stress and oxidative DNA damage are important in the pathogenesis of BPH. Higher oxidative stress markers in terms of Malondialdehyde levels was reported in BPH patients. Moreover, a systematic review revealed that prostatic inflammation can induce free radicals formation that might play role in carcinogenesis and development of prostate cancer in patients with BPH. Garcinia cambogia is a natural fruit which has been reported to have anti-obesity activity including reduced food intake and body fat gain by regulating the serotonin levels related to satiety, increased fat oxidation and decreased de novo lipogenesis. It also exerted hypolipidemic, antidiabetic, anti-inflammatory, anticancer, anthelmintic, anticholinesterase and hepatoprotective activities in in vitro and in vivo models . Hydro-citric acid, the main component of garcinia extract, has been reported to have strong antioxidant property. An animal study on rats has reported that kolaviron, a bioflavonoid complex from Garcinia kola had decreased prostate weights (compared with the normal control and reversed the histoarchitecture of the prostates of the BPH rats.

Official Title
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Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With Symptomatic Benign Prostatic Hypertrophy

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Chromax
* Drug: Sildosin Group
* Other: Placebo Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LUTS/BPH Exclusion Criteria: Previous prostatic surgery or radiation therapy. Treatment with anti-BPH drugs within a month before the beginning of study (washout) or, 5α-reductase inhibitor (5-ARI) use within 6 months prior to entry, use of drugs like LHRH. Patient receiving chromium and garcinia extract before inclusion in the study. complicated LUTS/BPH requring surgical treatment Neurogenic Bladder

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study Group A<br>patients will receive one capsule of [garcinia 500 mg and chromium 281 mg] 3 times daily for 12 weeks. | Drug: Chromax<br>* Treatment of BPH by Chromax for 3 Months<br>* Other names: study Group;|
| Active Comparator: Active control Group B<br>patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks | Drug: Sildosin Group<br>* patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks<br>* Other names: Active control Group A;|
| Placebo Comparator: Placebo Group C<br>patients will receive placebo 3 times daily for 12 weeks | Other: Placebo Group<br>* patients will receive placebo 3 times daily for 12 weeks<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-International prostate symptoms score(IPSS) | IPSS score Ranges from1 to 35, lower score is better | change of baseline and 3 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2- Volume of prostate(PV) | 2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5) | change of PV from baseline and 3 months post-treatment | 
| 4- Residual urine volume(PVRU) | Post voiding Residual urine volume normally about 0 | Change of PVRU from baseline and 3 months post-treatment | 
| Prostativ Specific Antigen (PSA) | PSA normally up to 4.5 ng/ml | Change of PSA from baseline to 3 months post-treatment | 
| Body Mass index (BMI) | BMI is about 25 | Change of BMI from baseline and 3 months post-treatment |