A Phase 2 interventional study of Chromax and Sildosin Group in Prostatic Hyperplasia, sponsored by Benha University. Status unknown at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Benha University · Phase 2, Interventional, and Treatment
To evaluate efficacy and safety of garcinia extract + chromium combinations (Chromax) in symptomatic benign prostatic hypertrophy patients
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 120 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients will receive one capsule of \[garcinia 500 mg and chromium 281 mg\] 3 times daily for 12 weeks.
Drug: Chromax
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
Drug: Sildosin Group
patients will receive placebo 3 times daily for 12 weeks
Other: Placebo Group
Treatment of BPH by Chromax for 3 Months
Also known as: study Group
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
Also known as: Active control Group A
patients will receive placebo 3 times daily for 12 weeks
Also known as: Placebo Comparator
1-International prostate symptoms score(IPSS)
IPSS score Ranges from1 to 35, lower score is better
Time frame: change of baseline and 3 months post-treatment
2- Volume of prostate(PV)
2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5)
Time frame: change of PV from baseline and 3 months post-treatment
4- Residual urine volume(PVRU)
Post voiding Residual urine volume normally about 0
Time frame: Change of PVRU from baseline and 3 months post-treatment
Prostativ Specific Antigen (PSA)
PSA normally up to 4.5 ng/ml
Time frame: Change of PSA from baseline to 3 months post-treatment
Body Mass index (BMI)
BMI is about 25
Time frame: Change of BMI from baseline and 3 months post-treatment
Quality of life(QOL)
QOL Ranges 1 to 6 lower values is better
Time frame: Change of QOL from baseline and 3 months post-treatment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Benha University