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

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    120
  • sponsor
    Benha University
Updated on 25 January 2021

Summary

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

Description

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.

Details
Condition Benign prostatic hypertrophy, Prostatic disorder, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), benign prostatic hyperplasia
Treatment Placebo group, Chromax, Sildosin Group
Clinical Study IdentifierNCT04590534
SponsorBenha University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Are you male?
Do you have any of these conditions: Benign Prostatic Hyperplasia (Enlarged Prostate) or Benign prostatic hypertrophy or Prostatic disorder or Prostate Disorders?
Do you have any of these conditions: Prostate Disorders or Prostatic disorder or benign prostatic hyperplasia or Benign Prostatic Hyperplasia (Enlarged Prostate) or Benign prostatic hyper...?
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, 5-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
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