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

Prostatic Hyperplasia Clinical Trial

— BPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590534
• Other study ID #: IDIRB2017122601-105
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: March 12, 2023

Study information

• Verified date: November 2022
• Source: Benha University
• Contact: Waleed El-Shaer, M.D
• Phone: +201015767331
• Email: waleed_elshaer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 12, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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, 5a-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

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Chromax
Treatment of BPH by Chromax for 3 Months
• Sildosin Group
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks

Other:
• Placebo Group
patients will receive placebo 3 times daily for 12 weeks

Locations

Country	Name	City	State
Egypt	Banha University Hospitals	Banha	Kalubyia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life(QOL)	QOL Ranges 1 to 6 lower values is better	Change of QOL from baseline and 3 months post-treatment
Primary	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	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
Secondary	4- Residual urine volume(PVRU)	Post voiding Residual urine volume normally about 0	Change of PVRU from baseline and 3 months post-treatment
Secondary	Prostativ Specific Antigen (PSA)	PSA normally up to 4.5 ng/ml	Change of PSA from baseline to 3 months post-treatment
Secondary	Body Mass index (BMI)	BMI is about 25	Change of BMI from baseline and 3 months post-treatment