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

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Chromax; Drug: Sildosin Group; Other: Placebo Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Waleed El-Shaer, M.D; Phone Number: +201015767331; Email: waleed_elshaer@hotmail.com

Study Locations

• Egypt
  • Kalubyia
    • Banhā, Kalubyia, Egypt, 13511
      • Recruiting
      • Banha University Hospitals
      • Contact: Waleed El-Shaer; Email: waleed.elshaer@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life(QOL)	QOL Ranges 1 to 6 lower values is better	Change of QOL from baseline and 3 months post-treatment

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Waleed El-Shaer, M.D, Banha Univesity

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): March 12, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: IDIRB2017122601-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No