Chronic ProstatitisEarly Phase 1NCT03946163
The Effect of Cinnamon on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome; a Pilot Study
A Early Phase 1 study testing cinnamon capsules in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by Al-Kindy College of Medicine at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- cinnamon capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2018to 30 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have symptoms of chronic prostatitis / chronic pelvic pain syndrome
- Duration of symptoms more than 6 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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
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)
Read the 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)
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- cinnamon capsules, Placebo oral capsule
- Keywords
- chronic prostatitis, chronic pelvic pain syndrome, cinnamon, herbal medicine, Traditional medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinnamon capsulesDietary 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
Placebo oral capsuleDrug
Also called Placebo
each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive response
A reduction in the NIH-CPSI score of 6 or more points from the initial score
Measured: 1 month
Secondary outcomes (1)
minor positive response
reduction in one or more the sub-scores of the NIH-CPSI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Feb 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tawfik J Al-Marzooq, F.I.C.M.S., Principal investigator, University of Baghdad- Alkindy collage of medicineQays A Al-Timimy, F.I.C.M.S., Principal investigator, University of Baghdad- Alkindy collage of medicineHarth M Kamber, F.I.C.M.S., Study director, University of Baghdad- Alkindy collage of medicineMalath A Hussein, F.I.C.M.S., Principal investigator, University of Baghdad- Alkindy collage of medicineAhmed A Marzouq, F.I.C.M.S., Principal investigator, University of Baghdad- Alkindy collage of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946163
- Sponsor's protocol ID
- 5 Al-KindyCM
- Status last verified
- Mar 2024
- First submitted
- 9 May 2019
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10422990Krieger 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.
PubMed 18164907Nickel JC. Prostatitis: myths and realities. Urology. 1998 Mar;51(3):362-6. doi: 10.1016/s0090-4295(97)00643-2.
PubMed 9510337Lee 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.
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.
PubMed 26378575Chen 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.
PubMed 24628250Senanayake 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.
PubMed 17826984Tung 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.
PubMed 20815702Rao 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.
PubMed 24817901Litwin 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.
PubMed 10411041Propert 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.
PubMed 16468084
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03946163
- Acronym / sponsor ID
- 5 Al-KindyCM
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Keywords
- chronic prostatitis, chronic pelvic pain syndrome, cinnamon, herbal medicine, Traditional medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Dietary Supplement: cinnamon capsuleseach patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month |
| second group | Placebo comparator | Drug: Placebo oral capsuleeach patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have symptoms of chronic prostatitis / chronic pelvic pain syndrome
- Duration of symptoms more than 6 months
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinnamon capsuleseach 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 | first group |
| Placebo oral capsuleAlso: Placeboeach patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month | Drug | second group |
Primary outcome
positive response
Time frame: 1 month
A reduction in the NIH-CPSI score of 6 or more points from the initial score
1 secondary outcome
minor positive response
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 10422990Krieger 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.
- Background: PubMed 18164907Krieger 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.
- Background: PubMed 9510337Nickel JC. Prostatitis: myths and realities. Urology. 1998 Mar;51(3):362-6. doi: 10.1016/s0090-4295(97)00643-2.
- BackgroundLee SW. Recent trend of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) management. Hanyang Medical Reviews. 2017;37(1):40-6.
- BackgroundHempen C-H, Fischer T. A materia medica for Chinese medicine: plants, minerals, and animal products: Elsevier Health Sciences; 2009.
- Background: PubMed 26378575Nabavi 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.
- Background: PubMed 24628250Chen 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.
- BackgroundSenanayake UM, Lee TH, Wills RB. Volatile constituents of cinnamon (Cinnamomum zeylanicum) oils. Journal of agricultural and food chemistry. 1978;26(4):822-4.
- Background: PubMed 17826984Tung 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.
- Background: PubMed 20815702Tung 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.
- Background: PubMed 24817901Rao 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.
- Background: PubMed 10411041Litwin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tawfik J Al-Marzooq, F.I.C.M.S. principal investigator
University of Baghdad- Alkindy collage of medicine
Qays A Al-Timimy, F.I.C.M.S. principal investigator
University of Baghdad- Alkindy collage of medicine
Harth M Kamber, F.I.C.M.S. study director
University of Baghdad- Alkindy collage of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cinnamon capsules in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by Al-Kindy College of Medicine at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive response (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946163, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.