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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03946163
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Al-Kindy College of Medicine

Study Description
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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 Intervention/treatment Phase
Chronic Prostatitis Chronic Pelvic Pain Syndrome Dietary Supplement: cinnamon capsules Drug: Placebo oral capsule 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
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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: the capsules of similar shape, size, color, and smell will be packed in in 60 capsules pack by the preparing pharmacist and labeled as 1 or 2 on the pack, the team will be informed by the content of each pack only after the conclusion of the study
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 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arms and Interventions
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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
Other Name: Placebo


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946163


Locations
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Iraq
Harth Kamber
Baghdad, (select), Iraq, 10064
Sponsors and Collaborators
Al-Kindy College of Medicine
Investigators
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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
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Publications:
Lee SW. Recent trend of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) management. Hanyang Medical Reviews. 2017;37(1):40-6.
Hempen C-H, Fischer T. A materia medica for Chinese medicine: plants, minerals, and animal products: Elsevier Health Sciences; 2009.
Senanayake UM, Lee TH, Wills RB. Volatile constituents of cinnamon (Cinnamomum zeylanicum) oils. Journal of agricultural and food chemistry. 1978;26(4):822-4.

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Responsible Party: Al-Kindy College of Medicine
ClinicalTrials.gov Identifier: NCT03946163    
Other Study ID Numbers: 5 Al-KindyCM
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Al-Kindy College of Medicine:
chronic prostatitis
chronic pelvic pain syndrome
cinnamon
herbal medicine
Traditional medicine
Additional relevant MeSH terms:
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Prostatitis
Syndrome
Pelvic Pain
Chronic Disease
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
 Pain
Neurologic Manifestations
Prostatic Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Disease Attributes