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

NCT04590534 | Unknown Phase 2

• 1 other identifier: IDIRB2017122601-105
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 2- Volume of prostate(PV)

  change of PV from baseline and 3 months post-treatment

• 4- Residual urine volume(PVRU)

  Change of PVRU from baseline and 3 months post-treatment

• Prostativ Specific Antigen (PSA)

  Change of PSA from baseline to 3 months post-treatment

• Body Mass index (BMI)

  Change of BMI from baseline and 3 months post-treatment

Other Outcomes (1)

• Quality of life(QOL)

  Change of QOL from baseline and 3 months post-treatment

Study Arms (3)

study Group A

EXPERIMENTAL

patients will receive one capsule of \[garcinia 500 mg and chromium 281 mg\] 3 times daily for 12 weeks.

Drug: Chromax

Active control Group B

ACTIVE COMPARATOR

patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks

Drug: Sildosin Group

Placebo Group C

PLACEBO COMPARATOR

patients will receive placebo 3 times daily for 12 weeks

Other: Placebo Group

Interventions

Chromax DRUG

Treatment of BPH by Chromax for 3 Months

Also known as: study Group

study Group A

Sildosin Group DRUG

patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks

Also known as: Active control Group A

Active control Group B

Placebo Group OTHER

patients will receive placebo 3 times daily for 12 weeks

Also known as: Placebo Comparator

Placebo Group C

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LUTS/BPH

You may not qualify if:

• 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.
• complicated LUTS/BPH requring surgical treatment Neurogenic Bladder

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University Hospitals

Banhā, Kalubyia, 13511, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 40209997 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Waleed El-Shaer, M.D

  Banha Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed El-Shaer, M.D

CONTACT

+201015767331; waleed_elshaer@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: March 12, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)