Prostatic HyperplasiaPhase 2BPHNCT04590534
Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With LUTS/BPH
A Phase 2 study testing Chromax and Sildosin Group in people with Prostatic Hyperplasia, run by Benha University at 1 site in Egypt.
Trial summary
To evaluate efficacy and safety of garcinia extract + chromium combinations (Chromax) in symptomatic benign prostatic hypertrophy patients Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Chromax and Sildosin Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 12 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LUTS/BPH
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banha University Hospitals
Banhā, Kalubyia, 13511
Waleed El-Shaer, waleed.elshaer@fmed.bu.edu.eg
About this study
Official title: 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
Read the 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.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Chromax, Sildosin Group, Placebo Group
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromaxDrug
Also called study Group
Treatment of BPH by Chromax for 3 Months
Sildosin GroupDrug
Also called Active control Group A
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
Placebo GroupOther
Also called Placebo Comparator
patients will receive placebo 3 times daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| study Group A | Experimental | patients will receive one capsule of [garcinia 500 mg and chromium 281 mg] 3 times daily for 12 weeks. Receives: Drug: Chromax |
| Active control Group B | Active comparator | patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks Receives: Drug: Sildosin Group |
| Placebo Group C | Placebo comparator | patients will receive placebo 3 times daily for 12 weeks Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-International prostate symptoms score(IPSS)
IPSS score Ranges from1 to 35, lower score is better
Measured: change of baseline and 3 months post-treatment
Secondary outcomes (4)
2- Volume of prostate(PV)
2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5)
Measured: change of PV from baseline and 3 months post-treatment
4- Residual urine volume(PVRU)
Post voiding Residual urine volume normally about 0
Measured: Change of PVRU from baseline and 3 months post-treatment
Prostativ Specific Antigen (PSA)
PSA normally up to 4.5 ng/ml
Measured: Change of PSA from baseline to 3 months post-treatment
Body Mass index (BMI)
BMI is about 25
Measured: Change of BMI from baseline and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2023 (estimated)
- Study completion12 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
- Investigators
- Waleed El-Shaer, M.D, Principal investigator, Banha Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590534
- Sponsor's protocol ID
- IDIRB2017122601-105
- Acronym
- BPH
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Shaer W, Abd-Allah AR, El-Shafie MF, Salama IM, El Shaer A. Evaluation of the Therapeutic Potential of Garcinia cambogia Alone or in Combination With Silodosin in the Management of LUTS/BPH: A Prospective Randomized Controlled Study. Urology. 2025 Jun;200:198-205. doi: 10.1016/j.urology.2025.04.012. Epub 2025 Apr 8.
PubMed 40209997
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With Symptomatic Benign Prostatic Hypertrophy
- ClinicalTrials.gov ID
- NCT04590534
- Acronym / sponsor ID
- BPH / IDIRB2017122601-105
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 12 Mar 2023 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of garcinia extract + chromium combinations (Chromax) in symptomatic benign prostatic hypertrophy patients
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| study Group A | Experimental | Drug: Chromaxpatients will receive one capsule of [garcinia 500 mg and chromium 281 mg] 3 times daily for 12 weeks. |
| Active control Group B | Active comparator | Drug: Sildosin Grouppatients will receive one capsule of Sidosin 8 mg once daily for 12 weeks |
| Placebo Group C | Placebo comparator | Other: Placebo Grouppatients will receive placebo 3 times daily for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LUTS/BPH
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChromaxAlso: study GroupTreatment of BPH by Chromax for 3 Months | Drug | study Group A |
| Sildosin GroupAlso: Active control Group Apatients will receive one capsule of Sidosin 8 mg once daily for 12 weeks | Drug | Active control Group B |
| Placebo GroupAlso: Placebo Comparatorpatients will receive placebo 3 times daily for 12 weeks | Other | Placebo Group C |
Primary outcome
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
4 secondary outcomes
2- Volume of prostate(PV)
Time frame: change of PV from baseline and 3 months post-treatment
4- Residual urine volume(PVRU)
Time frame: Change of PVRU from baseline and 3 months post-treatment
Prostativ Specific Antigen (PSA)
Time frame: Change of PSA from baseline to 3 months post-treatment
Body Mass index (BMI)
Time frame: Change of BMI from baseline and 3 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 40209997El-Shaer W, Abd-Allah AR, El-Shafie MF, Salama IM, El Shaer A. Evaluation of the Therapeutic Potential of Garcinia cambogia Alone or in Combination With Silodosin in the Management of LUTS/BPH: A Prospective Randomized Controlled Study. Urology. 2025 Jun;200:198-205. doi: 10.1016/j.urology.2025.04.012. Epub 2025 Apr 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed El-Shaer, M.D principal investigator
Banha Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chromax and Sildosin Group in people with Prostatic Hyperplasia, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed El-Shaer, M.D (+201015767331, waleed_elshaer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-International prostate symptoms score(IPSS) (time frame: change of baseline and 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.