Iraqi Traditional Medicine for Urinary Tract Symptoms: The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study
| Registry | NCT03946163 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 60 (Actual) |
| Sponsor | Al-Kindy College of Medicine (Other) |
| Conditions | Chronic Prostatitis, Chronic Pelvic Pain Syndrome |
| Interventions | cinnamon capsules, Placebo oral capsule (Dietary supplement, drug) |
| Dates | start 2018-02-01, primary completion 2019-06-30, completion 2019-06-30, first posted 2019-05-10, last updated 2024-04-02 |
| Locations | 1 site in Iraq |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Prostatitis All trials for Chronic Pelvic Pain Syndrome All trials of cinnamon capsules All trials of Placebo oral capsule
Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is one of the common urologic problems, nevertheless; its etiology and pathophysiology are poorly understood, with no solid guidelines for effective treatment. The beneficial health attributes of cinnamon and its derivative and components were reported by several researchers, this study is designed to illuminate the possible benefits of cinnamon on patients with Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS)
Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) defined as the "presence of genitourinary pain in the absence of uropathogenic bacteria detected by standard microbiologic methodology" by the National Institutes of Health (NIH) (1) The presence of symptoms resembling that of CP/CPPS in different population fall in the range between 2.2% and 9.7%, with a mean prevalence of 8.2%. making CP/CPPS one of the common urologic problems, nevertheless; its etiology and pathophysiology are poorly understood, with no solid guidelines for effective treatment (2, 3) Prolonged period of antibiotic therapy is usually used as the first line in treatment of CP/CPPS in the first place regardless of the finding of prostatic fluid microscopic examination and culture, when this failed, the next option in management that have been tried and investigated include medications such as alpha-blockers, anti-inflammatory drugs, muscle relaxants, anticonvulsants, or even hormonal manipulation, also physiotherapy, behavioral therapy, herbal or even surgical interventions all have been tried without conclusive evidence supporting the superiority of single treatment option over the others for all patients, making further studying and analysis desirable to get better understanding of the effectiveness of such options or even the trial of different treatment option in the hope of finding effective treatment. (4) Sandalwood (lignum Santali Albi), jasmine, and cinnamon are aromatic herbs that are traditionally used by for regulating qi, removing blood stasis, and relieving pain. (5) Previous studies found cinnamon had an antibacterial effect. (6) Cinnamon is the bark of trees belonging to the genus Cinnamomum. (7) Cinnamon has well known recognizable scent due to its oil content, which has a high concentration of the compound cinnamaldehyde in addition to several other compounds such as cinnamyl acetate, L-borneol, caryophyllene oxide, eugenol, b-caryophyllene, L-bornyl acetate, E-nerolidol, α-terpineol, α-cubebene, terpinolene, and α-thujene. In addition, cinnamon contains a variety of resinous compounds, including cinnamate, cinnamic acid. (8-10) Cinnamon has been long used in kitchens as spice and appetizer without reported serious adverse events. The beneficial health attributes of cinnamon and its derivative and components were reported by several researchers: these include its antimicrobial, anti-inflammatory, antioxidant action, anti-diabetic, and even anticancer actions .nevertheless; further studied are still required to illuminate the potential health benefits of the spice. (11) The National Institutes of Health Chronic Prostatitis Symptoms Index (NIH-CPSI) was developed as a tool to assess the severity of symptoms of CPPS. (12) A reduction of six or more points in NIH-CPSI score is considered clinically perceivable difference by the patients as confirmed by previous studies. (13)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| first group | Experimental | Dietary Supplement: cinnamon capsules | each patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month |
| second group | Placebo comparator | Drug: Placebo oral capsule | each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month |
Sex: Male, ages: 18 Years to any
Inclusion Criteria: 1. Have symptoms of chronic prostatitis / chronic pelvic pain syndrome 2. Duration of symptoms more than 6 months Exclusion Criteria: 1. Positive urine culture or positive prostatic secretions culture 2. Food allergies 3. Previous transurethral intervention, 4. Uncontrolled medical disease (such as diabetes, hypertension or asthma), 5. Use of analgesics for other conditions (like musculoskeletal pain or so)
| Facility | City | Country | Status |
|---|---|---|---|
| Harth Kamber | Baghdad, (select) | Iraq |