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

  • Clinicaltrials.gov identifier

    NCT03946163

  • Recruitment Status

    Completed

  • First Posted

    May 10, 2019

  • Last update posted

    August 5, 2019

Study Description

Brief summary:

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)

  • Condition or Disease:Chronic Prostatitis
    Chronic Pelvic Pain Syndrome
  • Intervention/Treatment: Dietary Supplement: cinnamon capsules
    Drug: Placebo oral capsule
  • Phase: Early Phase 1

Detailed 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)

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: The patients will be randomized into two groups, the first group will receive sixty capsules, each capsule contains 1gm of cinnamon bark powder and will be instructed to use it twice daily for one month, the second group will receive 60 capsules containing placebo and will be instructed to use it twice daily for one month
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Iraqi Traditional Medicine for Urinary Tract Symptoms: The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study
  • Actual Study Start Date: February 2018
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: June 2019

Arms and interventions

Arm Intervention/treatment
Experimental: first group
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 1gm of cinnamon bark powder and instructed to use it twice daily for one month
Placebo Comparator: second group
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 placebo and instructed to use it twice daily for one month

Outcome Measures

  • Primary Outcome Measures: 1. positive response [ Time Frame: 1 month ]
    A reduction in the NIH-CPSI score of 6 or more points from the initial score
  • Secondary Outcome Measures: 1. minor positive response [ Time Frame: 1 month ]
    reduction in one or more the sub-scores of the NIH-CPSI

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Locations

Iraq, (select)
Harth Kamber
Baghdad

Sponsors and Collaborators

Al-Kindy College of Medicine

Investigators

Principal Investigator: Tawfik J Al-Marzooq, F.I.C.M.S. University of Baghdad- Alkindy collage of medicine

Principal Investigator: Qays A Al-Timimy, F.I.C.M.S. University of Baghdad- Alkindy collage of medicine

Study Director: Harth M Kamber, F.I.C.M.S. University of Baghdad- Alkindy collage of medicine

Principal Investigator: Malath A Hussein, F.I.C.M.S. University of Baghdad- Alkindy collage of medicine

Principal Investigator: Ahmed A Marzouq, F.I.C.M.S. University of Baghdad- Alkindy collage of medicine

More Information