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

NCT03946163 | Completed Early Phase 1

• 1 other identifier: 5 Al-KindyCM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Keywords

chronic prostatitis; chronic pelvic pain syndrome; cinnamon; herbal medicine; Traditional medicine

Outcome Measures

Primary Outcomes (1)

• positive response

  A reduction in the NIH-CPSI score of 6 or more points from the initial score

  1 month

Secondary Outcomes (1)

• minor positive response

  1 month

Study Arms (2)

first group

EXPERIMENTAL

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

second group

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

cinnamon capsules DIETARY_SUPPLEMENT

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

first group

Placebo oral capsule DRUG

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

Also known as: Placebo

second group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have symptoms of chronic prostatitis / chronic pelvic pain syndrome
• Duration of symptoms more than 6 months

You may not qualify if:

• Positive urine culture or positive prostatic secretions culture
• Food allergies
• Previous transurethral intervention,
• Uncontrolled medical disease (such as diabetes, hypertension or asthma),
• Use of analgesics for other conditions (like musculoskeletal pain or so)

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead

Study Sites (1)

Harth Kamber

Baghdad, (select), 10064, Iraq

Location

Related Publications (13)

• 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.

  PMID: 10422990 BACKGROUND

• 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.

  PMID: 18164907 BACKGROUND

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

  PMID: 9510337 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26378575 BACKGROUND

• 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.

  PMID: 24628250 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17826984 BACKGROUND

• 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.

  PMID: 20815702 BACKGROUND

• 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.

  PMID: 24817901 BACKGROUND

• 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.

  PMID: 10411041 BACKGROUND

• 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.

  PMID: 16468084 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Harth M Kamber, F.I.C.M.S.

  University of Baghdad- Alkindy collage of medicine

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: February 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IR (1)