Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With LUTS/BPH (BPH)
Primary Purpose
Prostatic Hyperplasia
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Chromax
Sildosin Group
Placebo Group
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility 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
Sites / Locations
- Banha University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
study Group A
Active control Group B
Placebo Group C
Arm Description
patients will receive one capsule of [garcinia 500 mg and chromium 281 mg] 3 times daily for 12 weeks.
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
patients will receive placebo 3 times daily for 12 weeks
Outcomes
Primary Outcome Measures
1-International prostate symptoms score(IPSS)
IPSS score Ranges from1 to 35, lower score is better
Secondary Outcome Measures
2- Volume of prostate(PV)
2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5)
4- Residual urine volume(PVRU)
Post voiding Residual urine volume normally about 0
Prostativ Specific Antigen (PSA)
PSA normally up to 4.5 ng/ml
Body Mass index (BMI)
BMI is about 25
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04590534
Brief Title
Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With LUTS/BPH
Acronym
BPH
Official Title
Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With Symptomatic Benign Prostatic Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
March 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study Group A
Arm Type
Experimental
Arm Description
patients will receive one capsule of [garcinia 500 mg and chromium 281 mg] 3 times daily for 12 weeks.
Arm Title
Active control Group B
Arm Type
Active Comparator
Arm Description
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
Arm Title
Placebo Group C
Arm Type
Placebo Comparator
Arm Description
patients will receive placebo 3 times daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Chromax
Other Intervention Name(s)
study Group
Intervention Description
Treatment of BPH by Chromax for 3 Months
Intervention Type
Drug
Intervention Name(s)
Sildosin Group
Other Intervention Name(s)
Active control Group A
Intervention Description
patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Group
Other Intervention Name(s)
Placebo Comparator
Intervention Description
patients will receive placebo 3 times daily for 12 weeks
Primary Outcome Measure Information:
Title
1-International prostate symptoms score(IPSS)
Description
IPSS score Ranges from1 to 35, lower score is better
Time Frame
change of baseline and 3 months post-treatment
Secondary Outcome Measure Information:
Title
2- Volume of prostate(PV)
Description
2- measred prostate Volume mesured by transrectal ultra sound (normal 20+- 5)
Time Frame
change of PV from baseline and 3 months post-treatment
Title
4- Residual urine volume(PVRU)
Description
Post voiding Residual urine volume normally about 0
Time Frame
Change of PVRU from baseline and 3 months post-treatment
Title
Prostativ Specific Antigen (PSA)
Description
PSA normally up to 4.5 ng/ml
Time Frame
Change of PSA from baseline to 3 months post-treatment
Title
Body Mass index (BMI)
Description
BMI is about 25
Time Frame
Change of BMI from baseline and 3 months post-treatment
Other Pre-specified Outcome Measures:
Title
Quality of life(QOL)
Description
QOL Ranges 1 to 6 lower values is better
Time Frame
Change of QOL from baseline and 3 months post-treatment
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed El-Shaer, M.D
Phone
+201015767331
Email
waleed_elshaer@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-Shaer, M.D
Organizational Affiliation
Banha Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University Hospitals
City
Banhā
State/Province
Kalubyia
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waleed El-Shaer
Email
waleed.elshaer@fmed.bu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effect of Garcinia in Combination With Chromium on the Clinical Outcomes of Patients With LUTS/BPH
We'll reach out to this number within 24 hrs