Pomegranate (P. Granatum) Peel CompressPomegranateNCT06034106
The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status
A study testing Pomegranate (Punica granatum) peel compress and Hot compress in people with Pomegranate (P. Granatum) Peel Compress, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pomegranate (P. Granatum) Peel Compress
- What is being tested?
- Pomegranate (Punica granatum) peel compress and Hot compress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2023to 15 Oct 2023
- Phase
- Interventional
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Visual analog scale score of 3 and above,
- those aged 45 and over,
- Diagnosed with knee OA by a physician according to the criteria of the American - Rheumatology Association (ARD),
- pain lasting at least 1 month or longer,
- not included in any physical therapy program during the research period, a
- capable of answering research questions,
- agreeing to participate in the research by giving verbal and written consent
Who cannot join
- with a defined psychiatric illness,
- having vision and hearing problems,
- diagnosed with complex disease such as malignant,
- having a wound in the application area,
- with a diagnosed vascular disease,
- the patient's other inflammatory disease such as rheumatoid arthritis, gout, fibromyalgia
- who have had serious trauma or surgery in the last 6 months,
- who have received DMARDS or intra-articular steroid injection therapy in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status in Patients With Knee Osteoarthritis
Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. For this purpose, patients diagnosed with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included. It was calculated that the study would include at least 67 patients. The study will be collected using patient information form, descriptive characteristics form, Visual Analog Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (P. granatum) compress application on pain and function status. The study was divided into 3 groups as Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
Read the detailed description
This randomized controlled experimental study was conducted to evaluate the effect of pomegranate (Punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.
- Conditions
- Pomegranate (P. Granatum) Peel Compress
- Being tested
- Pomegranate (Punica granatum) peel compress, Hot compress
- Keywords
- pain, osteoarthritis, rheumatologic diseases, physical function, stiffness, nursing
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate (Punica granatum) peel compressBehavioural
Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
Hot compressBehavioural
Hot compress was applied 3 days a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate (P. granatum) peel compress group | Experimental | 36 g of pomegranate peel powder was given to the patient in a closed container. A teaspoon (approximately 2-3 g) of powder was mixed with water from the storage container and applied to the patient's knee by making a paste, and then the knee was wrapped with a bandage. It was kept for 20 minutes by placing a hot thermophore (approximately 40-45 C) on it. This application was carried out 3 days a week. Receives: Behavioral: Pomegranate (Punica granatum) peel compress |
| Hot compress | Placebo comparator | In the hot compress group, the knee was wrapped with a bandage and the hot thermophor (approximately 40-45 °C) was placed on the knee. The hot thermoform was applied to the patient 3 days a week by keeping it for 20 minutes. Receives: Behavioral: Pomegranate (Punica granatum) peel compress; Behavioral: Hot compress |
| Control Group | No intervention | Patients in the control group did not receive any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient
Measured: The scale was filled in the baseline
WOMAC Osteoarthritis Index
The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.
Measured: The scale was filled in the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start14 Apr 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pomegranate (P. Granatum) Peel CompressStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Efe Arslan, TC Erciyes University
- Investigators
- DİLEK EFE ARSLAN, Study director, ERCİYES UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034106
- Sponsor's protocol ID
- getat51
- Acronym
- Pomegranate
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06034106
- Acronym / sponsor ID
- Pomegranate / getat51
- Conditions
- Pomegranate (P. Granatum) Peel Compress
- Keywords
- pain, osteoarthritis, rheumatologic diseases, physical function, stiffness, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 13 Sep 2023 (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.
Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. For this purpose, patients diagnosed with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included. It was calculated that the study would include at least 67 patients. The study will be collected using patient information form, descriptive characteristics form, Visual Analog Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (P. granatum) compress application on pain and function status. The study was divided into 3 groups as Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
Detailed description
This randomized controlled experimental study was conducted to evaluate the effect of pomegranate (Punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pomegranate (P. granatum) peel compress group | Experimental | Behavioral: Pomegranate (Punica granatum) peel compress36 g of pomegranate peel powder was given to the patient in a closed container. A teaspoon (approximately 2-3 g) of powder was mixed with water from the storage container and applied to the patient's knee by making a paste, and then the knee was wrapped with a bandage. It was kept for 20 minutes by placing a hot thermophore (approximately 40-45 C) on it. This application was carried out 3 days a week. |
| Hot compress | Placebo comparator | Behavioral: Pomegranate (Punica granatum) peel compress, Behavioral: Hot compressIn the hot compress group, the knee was wrapped with a bandage and the hot thermophor (approximately 40-45 °C) was placed on the knee. The hot thermoform was applied to the patient 3 days a week by keeping it for 20 minutes. |
| Control Group | No intervention | –Patients in the control group did not receive any additional intervention. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Visual analog scale score of 3 and above,
- those aged 45 and over,
- Diagnosed with knee OA by a physician according to the criteria of the American - Rheumatology Association (ARD),
- pain lasting at least 1 month or longer,
- not included in any physical therapy program during the research period, a
Key exclusion criteria (8 listed)
- with a defined psychiatric illness,
- having vision and hearing problems,
- diagnosed with complex disease such as malignant,
- having a wound in the application area,
- with a diagnosed vascular disease,
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 |
|---|---|---|
| Pomegranate (Punica granatum) peel compressPomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check. | Behavioural | Hot compress, Pomegranate (P. granatum) peel compress group |
| Hot compressHot compress was applied 3 days a week for 3 weeks. | Behavioural | Hot compress |
Primary outcome
Visual Analog Scale
Time frame: The scale was filled in the baseline
A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient
WOMAC Osteoarthritis Index
Time frame: The scale was filled in the baseline
The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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.
DİLEK EFE ARSLAN study director
ERCİYES UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate (Punica granatum) peel compress and Hot compress in people with Pomegranate (P. Granatum) Peel Compress, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
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?
Visual Analog Scale (time frame: The scale was filled in the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.