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

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ClinicalTrials.gov Identifier: NCT04590534
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Waleed El-Shaer, MD, Benha University

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

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: Chromax Drug: Sildosin Group Other: Placebo Group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With Symptomatic Benign Prostatic Hypertrophy
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : June 12, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Chromium

Arms and Interventions
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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 Name: 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 Name: 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 Name: Placebo Comparator


Outcome Measures
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Primary Outcome Measures :
  1. 1-International prostate symptoms score(IPSS) [ Time Frame: change of baseline and 3 months post-treatment ]
    IPSS score Ranges from1 to 35, lower score is better


Secondary Outcome Measures :
  1. 2- Volume of prostate(PV) [ Time Frame: change of PV from baseline and 3 months post-treatment ]
    2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5)

  2. 4- Residual urine volume(PVRU) [ Time Frame: Change of PVRU from baseline and 3 months post-treatment ]
    Post voiding Residual urine volume normally about 0

  3. Prostativ Specific Antigen (PSA) [ Time Frame: Change of PSA from baseline to 3 months post-treatment ]
    PSA normally up to 4.5 ng/ml

  4. Body Mass index (BMI) [ Time Frame: Change of BMI from baseline and 3 months post-treatment ]
    BMI is about 25


Other Outcome Measures:
  1. Quality of life(QOL) [ Time Frame: Change of QOL from baseline and 3 months post-treatment ]
    QOL Ranges 1 to 6 lower values is better


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590534


Contacts
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Contact: Waleed El-Shaer, M.D +201015767331 waleed_elshaer@hotmail.com

Locations
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Egypt
Banha University Hospitals Recruiting
Banhā, Kalubyia, Egypt, 13511
Contact: Waleed El-Shaer       waleed.elshaer@fmed.bu.edu.eg   
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Waleed El-Shaer, M.D Banha Univesity
More Information
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Responsible Party: Waleed El-Shaer, MD, Principal Investigator, Benha University
ClinicalTrials.gov Identifier: NCT04590534    
Other Study ID Numbers: IDIRB2017122601-105
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases