An Early Phase 1 interventional study of cinnamon capsules and Placebo oral capsule in Chronic Prostatitis and Chronic Pelvic Pain Syndrome, sponsored by Al-Kindy College of Medicine. Completed at 1 site in Iraq. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Al-Kindy College of Medicine · Early Phase 1, Interventional, and Treatment
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)
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Al-Kindy College of Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
each patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month
Dietary Supplement: cinnamon capsules
each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
Drug: Placebo oral capsule
each patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month
each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
Also known as: Placebo
positive response
A reduction in the NIH-CPSI score of 6 or more points from the initial score
Time frame: 1 month
minor positive response
reduction in one or more the sub-scores of the NIH-CPSI
Time frame: 1 month
Ran from Feb 2018 to primary completion in Jun 2019, 16 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinnamon
Al-Kindy College of Medicine