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

Primary Purpose

Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Status
Completed
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
cinnamon capsules
Placebo oral capsule
Sponsored by
Al-Kindy College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis focused on measuring chronic prostatitis, chronic pelvic pain syndrome, cinnamon, herbal medicine, Traditional medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

  • Harth Kamber

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

first group

second group

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

minor positive response
reduction in one or more the sub-scores of the NIH-CPSI

Full Information

First Posted
May 9, 2019
Last Updated
April 27, 2023
Sponsor
Al-Kindy College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03946163
Brief Title
The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Kindy College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Keywords
chronic prostatitis, chronic pelvic pain syndrome, cinnamon, herbal medicine, Traditional medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first group
Arm Type
Experimental
Arm 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
Arm Title
second group
Arm Type
Placebo Comparator
Arm Description
each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
Intervention Type
Dietary Supplement
Intervention Name(s)
cinnamon capsules
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
Primary Outcome Measure Information:
Title
positive response
Description
A reduction in the NIH-CPSI score of 6 or more points from the initial score
Time Frame
1 month
Secondary Outcome Measure Information:
Title
minor positive response
Description
reduction in one or more the sub-scores of the NIH-CPSI
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have symptoms of chronic prostatitis / chronic pelvic pain syndrome Duration of symptoms more than 6 months Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawfik J Al-Marzooq, F.I.C.M.S.
Organizational Affiliation
University of Baghdad- Alkindy collage of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qays A Al-Timimy, F.I.C.M.S.
Organizational Affiliation
University of Baghdad- Alkindy collage of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harth M Kamber, F.I.C.M.S.
Organizational Affiliation
University of Baghdad- Alkindy collage of medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Malath A Hussein, F.I.C.M.S.
Organizational Affiliation
University of Baghdad- Alkindy collage of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed A Marzouq, F.I.C.M.S.
Organizational Affiliation
University of Baghdad- Alkindy collage of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harth Kamber
City
Baghdad
State/Province
(select)
ZIP/Postal Code
10064
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
10422990
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.
Results Reference
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PubMed Identifier
18164907
Citation
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.
Results Reference
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PubMed Identifier
9510337
Citation
Nickel JC. Prostatitis: myths and realities. Urology. 1998 Mar;51(3):362-6. doi: 10.1016/s0090-4295(97)00643-2.
Results Reference
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Citation
Lee SW. Recent trend of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) management. Hanyang Medical Reviews. 2017;37(1):40-6.
Results Reference
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Citation
Hempen C-H, Fischer T. A materia medica for Chinese medicine: plants, minerals, and animal products: Elsevier Health Sciences; 2009.
Results Reference
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PubMed Identifier
26378575
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.
Results Reference
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PubMed Identifier
24628250
Citation
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.
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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.
Results Reference
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PubMed Identifier
17826984
Citation
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.
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PubMed Identifier
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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.
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PubMed Identifier
24817901
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.
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PubMed Identifier
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Citation
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.
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Citation
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The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study

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