Comparison the effect of Cucumis Melo L seeds oral product and Tamsulosin with Tamsulosin and placebo in reducing the symptoms of patients with benign prostatic hypertrophy.

General goal Use of Cucumis melo L seeds in the treatment of lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients.

This study is a prospective human clinical trial ,that will be done ,on 80 men with benign prostatic hyperplasia (BPH) in the age group of 45 to 75 years, who referred to Hasheminejad Hospital clinic and had symptoms of lower urinary tract symptoms (LUTS).

Inclusion criteria All patients aged 45 to 75 years with BPH, including at least one of the following, have an International Score of Prostate Symptoms (IPSS) greater than 13 at screening, a PSA greater than 3 ng / ml, and a prostate volume greater than 30 mm. Cube diagnosed by ultrasound, and patients who are able and willing to sign written consent. Exclusion criteria Surgery, infection, lower urinary tract disease (bladder stones, neurogenic bladder, bladder malignancy, urethral stricture, hematuria), Diabetes, Heart disease (heart failure, MI, unstable angina), uncontrolled hepato-renal disease, use of effective drugs Bladder and prostate (anticholinergics, sympathomimetics, antidepressants) Patients who are unable to use oral medication. Perform any drug intervention simultaneously. Allergy to medicinal plants.

Intervention group: Will received Tamsulosin (0.4 mg per night, 1 piece) with Cucumis melo L seeds 500 mg oral capsule three times daily after each meal for up to 6 weeks. The medicine is made by a pharmacist. The control group received Tamsulosin (0.4 mg 1 per night) with placebo oral capsules (500 mg of starch) three times daily after each meal for up to 6 weeks.

Patients' urinary symptoms

Using the balanced block randomization method. Random division is done in the form of "blocks" of predetermined size. For example, if the size of block is 6, the operation of random division until the third one person is randomly assigned to one group, and then individuals are automatically assigned to another group until a 6-piece block is completed. The features of this method are that it is easy to implement and balance in the number of groups is guaranteed.

In this study, in addition to the patient, health care personnel, data collectors, and those evaluating the outcome are blinded.

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