PrimiparityQSJNCT04536597
Quince Seed Jelly and Breast Milk on Nipple Fissures
A study testing Quince seed jelly group and Breast milk group in people with Primiparity and Postpartum, run by Cumhuriyet University.
Trial summary
Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood… Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparity, Postpartum
- What is being tested?
- Quince seed jelly group and Breast milk group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2015to 10 May 2017
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparity,
- those having no nipple problems and allergy history
- volunteered to participate in the study
Who cannot join
- nipple problems and allergy history
- multiparity
About this study
Official title: The Effects of Quince Seed Jelly and Breast Milk on Nipple Fissures During Early Postpartum
Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood circulation) and has no side effects or contraindications.
Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.
Methods: Randomised controlled experimental study.
- Conditions
- Primiparity, Postpartum
- Being tested
- Quince seed jelly group, Breast milk group, Control group
- Keywords
- breast milk, early postpartum period, nipple fissures, midwifery, quince seed jelly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quince seed jelly groupOther
Quince seed jelly, prepared by the researcher, was given to the mothers belonging to this group. Briefly, 3 g (2-3 pieces) of quince seeds are placed in 100 mL water and heated to boiling for 10 min. The prepared quince kernel was used for 3 days, immediately after cooling.14,15 On the 1st day postpartum, the researcher provided the mothers with practical training at the hospital, regarding the application of quince seed jelly to the nipple and areola and leaving it to dry. This training was repeated on the 3rd, 7th and 10th days, to ensure that the mothers followed it precisely. The training process was completed in 5-10 min, including questions and answers. Every 3-4 days (days 1, 3, 7 and 10), quince seed jelly prepared by the researcher was given to the mothers to continue applying, according to the procedure. The mothers were asked to apply it after every breastfeeding.
Breast milk groupOther
Mothers in this group received practical training, conducted by the researcher on the 1st day postpartum at the hospital, on applying a few drops of their breast milk to the nipples and areola after each breastfeeding and leaving it to dry. This training lasted 5-10 min. Breast milk application of mothers in this group was recorded on the 1st, 3rd, 7th and 10th days, by the researcher.
Control groupOther
Any kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher
| Study group | Role | What they receive |
|---|---|---|
| Quince seed jelly group | Experimental | Not described Receives: Other: Quince seed jelly group |
| Breast milk group | Experimental | Not described Receives: Other: Breast milk group |
| Control group | Other | Any kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple pains and fissures
the Breast Care Monitoring Form
Measured: between the 1st and 10th days of the postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start15 Oct 2015
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrimiparityStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulbahtiyar DEMİREL, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536597
- Sponsor's protocol ID
- TRSIVAS01
- Acronym
- QSJ
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Quince Seed Jelly and Breast Milk on Nipple Fissures During Early Postpartum
- ClinicalTrials.gov ID
- NCT04536597
- Acronym / sponsor ID
- QSJ / TRSIVAS01
- Conditions
- Primiparity, Postpartum
- Keywords
- breast milk, early postpartum period, nipple fissures, midwifery, quince seed jelly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 2 Sep 2020 (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.
Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood circulation) and has no side effects or contraindications.
Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.
Methods: Randomised controlled experimental study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quince seed jelly group | Experimental | Other: Quince seed jelly group |
| Breast milk group | Experimental | Other: Breast milk group |
| Control group | Other | Other: Control groupAny kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- primiparity,
- those having no nipple problems and allergy history
- volunteered to participate in the study
Key exclusion criteria (2 listed)
- nipple problems and allergy history
- multiparity
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 |
|---|---|---|
| Quince seed jelly groupQuince seed jelly, prepared by the researcher, was given to the mothers belonging to this group. Briefly, 3 g (2-3 pieces) of quince seeds are placed in 100 mL water and heated to boiling for 10 min. The prepared quince kernel was used for 3 days, immediately after cooling.14,15 On the 1st day postpartum, the researcher provided the mothers with practical training at the hospital, regarding the application of quince seed jelly to the nipple and areola and leaving it to dry. This training was repeated on the 3rd, 7th and 10th days, to ensure that the mothers followed it precisely. The training process was completed in 5-10 min, including questions and answers. Every 3-4 days (days 1, 3, 7 and 10), quince seed jelly prepared by the researcher was given to the mothers to continue applying, according to the procedure. The mothers were asked to apply it after every breastfeeding. | Other | Quince seed jelly group |
| Breast milk groupMothers in this group received practical training, conducted by the researcher on the 1st day postpartum at the hospital, on applying a few drops of their breast milk to the nipples and areola after each breastfeeding and leaving it to dry. This training lasted 5-10 min. Breast milk application of mothers in this group was recorded on the 1st, 3rd, 7th and 10th days, by the researcher. | Other | Breast milk group |
| Control groupAny kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher | Other | Control group |
Primary outcome
Nipple pains and fissures
Time frame: between the 1st and 10th days of the postpartum period
the Breast Care Monitoring Form
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 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quince seed jelly group and Breast milk group in people with Primiparity and Postpartum, run by Cumhuriyet University.
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 3 inclusion and 2 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
Nipple pains and fissures (time frame: between the 1st and 10th days of the postpartum period). 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 2 Sep 2020.