The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study

Al-Kindy College of Medicine

Status and phase: Completed; Early Phase 1

Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Treatments: Dietary Supplement: cinnamon capsules; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03946163

5 Al-KindyCM

Details and patient eligibility

About

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)

Full description

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)

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

first group

Experimental group

Description:

each patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month

Treatment:

Dietary Supplement: cinnamon capsules

second group

Placebo Comparator group

Description:

each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month

Treatment:

Drug: Placebo oral capsule