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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-03-12

Brief Summary

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

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Detailed Description

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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

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Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study Group A

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

Group Type EXPERIMENTAL

Chromax

Intervention Type DRUG

Treatment of BPH by Chromax for 3 Months

Active control Group B

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

Group Type ACTIVE_COMPARATOR

Sildosin Group

Intervention Type DRUG

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

Placebo Group C

patients will receive placebo 3 times daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type OTHER

patients will receive placebo 3 times daily for 12 weeks

Interventions

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Chromax

Treatment of BPH by Chromax for 3 Months

Intervention Type DRUG

Sildosin Group

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

Intervention Type DRUG

Placebo Group

patients will receive placebo 3 times daily for 12 weeks

Intervention Type OTHER

Other Intervention Names

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study Group Active control Group A Placebo Comparator

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No