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

Chronic Pelvic Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946163
• Other study ID #: 5 Al-KindyCM
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2024
• Source: Al-Kindy College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Iraq	Harth Kamber	Baghdad	(select)

Sponsors (1)

Lead Sponsor	Collaborator
Al-Kindy College of Medicine

Country where clinical trial is conducted

Iraq, 

References & Publications (13)

Chen P, Sun J, Ford P. Differentiation of the four major species of cinnamons (C. burmannii, C. verum, C. cassia, and C. loureiroi) using a flow injection mass spectrometric (FIMS) fingerprinting method. J Agric Food Chem. 2014 Mar 26;62(12):2516-21. doi: 10.1021/jf405580c. Epub 2014 Mar 17. — View Citation

Hempen C-H, Fischer T. A materia medica for Chinese medicine: plants, minerals, and animal products: Elsevier Health Sciences; 2009.

Krieger JN, Lee SW, Jeon J, Cheah PY, Liong ML, Riley DE. Epidemiology of prostatitis. Int J Antimicrob Agents. 2008 Feb;31 Suppl 1(Suppl 1):S85-90. doi: 10.1016/j.ijantimicag.2007.08.028. Epub 2007 Dec 31. — View Citation

Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. doi: 10.1001/jama.282.3.236. No abstract available. — View Citation

Lee SW. Recent trend of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) management. Hanyang Medical Reviews. 2017;37(1):40-6.

Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x. — View Citation

Nabavi SF, Di Lorenzo A, Izadi M, Sobarzo-Sanchez E, Daglia M, Nabavi SM. Antibacterial Effects of Cinnamon: From Farm to Food, Cosmetic and Pharmaceutical Industries. Nutrients. 2015 Sep 11;7(9):7729-48. doi: 10.3390/nu7095359. — View Citation

Nickel JC. Prostatitis: myths and realities. Urology. 1998 Mar;51(3):362-6. doi: 10.1016/s0090-4295(97)00643-2. — View Citation

Propert KJ, Litwin MS, Wang Y, Alexander RB, Calhoun E, Nickel JC, O'Leary MP, Pontari M, McNaughton-Collins M; Chronic Prostatitis Collaborative Research Network (CPCRN). Responsiveness of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). Qual Life Res. 2006 Mar;15(2):299-305. doi: 10.1007/s11136-005-1317-1. — View Citation

Rao PV, Gan SH. Cinnamon: a multifaceted medicinal plant. Evid Based Complement Alternat Med. 2014;2014:642942. doi: 10.1155/2014/642942. Epub 2014 Apr 10. — View Citation

Senanayake UM, Lee TH, Wills RB. Volatile constituents of cinnamon (Cinnamomum zeylanicum) oils. Journal of agricultural and food chemistry. 1978;26(4):822-4.

Tung YT, Chua MT, Wang SY, Chang ST. Anti-inflammation activities of essential oil and its constituents from indigenous cinnamon (Cinnamomum osmophloeum) twigs. Bioresour Technol. 2008 Jun;99(9):3908-13. doi: 10.1016/j.biortech.2007.07.050. Epub 2007 Sep 10. — View Citation

Tung YT, Yen PL, Lin CY, Chang ST. Anti-inflammatory activities of essential oils and their constituents from different provenances of indigenous cinnamon (Cinnamomum osmophloeum) leaves. Pharm Biol. 2010 Oct;48(10):1130-6. doi: 10.3109/13880200903527728. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive response	A reduction in the NIH-CPSI score of 6 or more points from the initial score	1 month
Secondary	minor positive response	reduction in one or more the sub-scores of the NIH-CPSI	1 month