AromatherapyNCT05677698
Menoupausal Symptoms and Aromatherapy
A study testing Lemon oil, peppermint oil and Almond oil in people with Aromatherapy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Aromatherapy is "highly distilled herbs distilled to take advantage of their therapeutic properties". is the science of using concentrated essential oils or essences".Essential oils or essences are obtained from various parts of plants (root, leaves, flowers, bark, fruit) and used therapeutically for physical and… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy
- What is being tested?
- Lemon oil, peppermint oil and Almond oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2022to 27 Feb 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experiencing at least 1 of the menopausal symptoms (self-report),
- No respiratory disease such as asthma, bronchitis (self-report),
- Not allergic to the oils to be used (self-report),
Who cannot join
- Not experiencing menopausal complaints,
- Those who do not want to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Aromatherapy is "highly distilled herbs distilled to take advantage of their therapeutic properties".
is the science of using concentrated essential oils or essences".Essential oils or essences are obtained from various parts of plants (root, leaves, flowers, bark, fruit) and used therapeutically for physical and psychological well-being. The fact that aromatherapy is a noninvasive procedure and its ease of use allows for widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These include topical (tap, compress, or bath), internal (mouthwash, vaginal, or anal suppository), oral (with capsules or reconstitution in honey, alcohol, or diluent), and inhalation (direct or indirect, with or without steam, inhalation). ). Essential oils, which can be applied in various ways, can directly reach the neocortex part of the brain through connections extending from the limbic system to the hypothalamus via scent.
Read the detailed description
As a result of the effect of aromatic oils on the central nervous system, relaxation, sedation or stimulating effects occur and the information flow reaching the brain with the stimulation of the central nervous system.
Thanks to this, the energy blockage in the body is broken and as a result, energy is released. With the balanced distribution of the energy flow to the relevant organs, the healing process is supported, and physical and mental well-being emerges . Aromatherapy is used in many health fields as well as women's health. Menopause is a process in which physiological, psychological and hormonal changes occur in the life of all women . The World Health Organization defines menopause as "the permanent cessation of menstruation with loss of ovarian activity" . In addition to physical symptoms such as hot flashes, sweating, headache, low libido, fatigue, sleep disorders, palpitations, which occur as a result of the decrease in estrogen and progesterone hormone secretion and its end over time, psychological symptoms such as anxiety, depression and mood disorders are frequently encountered . Due to the increase in the number of women in the menopausal period in the world, it is important to reduce menopausal complaints and improve women's health.Studies have shown that aromatherapy is a complementary method used in a wide variety of situations to reduce physiological and psychological symptoms . It is stated that menopausal symptoms decrease in women who smell lavender aroma during menopause . It is important that the symptoms seen during menopause, which is an important part of a woman's life, are reduced and that women can spend this process more comfortably. While the age at menopause is in the range of 50-51 years worldwide, it is reported that the age of menopause in our country is between the ages of 47-49 . From this point of view, women spend about one third of their lives during and after menopause. The trend towards traditional and complementary medicine is increasing day by day in our country. However, in addition to the widespread use of aromatherapy in the world, aromatherapy practices are not common in our country. Diluted and ready-to-use forms of aromatic oils are not only available in pharmacies and herbalists, but also a method that people are curious about and want to use. The fact that the cost of ready-to-use aromatic oils is cheaper than drugs and easily accessible will provide women with a treatment option in the light of new evidence in line with the conduct of the study. In studies in the literature, it is stated that lavender, rose, geranium, and citrus oils are massaged to women in the menopausal period and provide mental and physical relaxation. Therefore, in our study, the use of Peppermint and Lemon oils to reduce the symptoms of menopausal women and increase their psychosocial well-being. is planned. Peppermint (Mentha Piperita) oil has analgesic, immune system strengthening, antispasmodic, antipyretic, anti-nausea and vomiting, anesthetic, helps concentration, increases self-confidence and creative thoughts, and Lemon (Citrus Lemon) oil is analgesic, immune-enhancing, antipyretic. It is thought that it can help relieve the psychological and physiological complaints of women in the menopausal period due to its properties such as helping constipation, reducing nausea and vomiting, increasing sleep quality, relieving stress and antidepressant. For this reason, it is planned to use Peppermint and Lemon oils in our study.
- Conditions
- Aromatherapy
- Being tested
- Lemon oil, peppermint oil, Almond oil
- Keywords
- aromatherapy, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemon oilOther
Lemon oil with massage
peppermint oilOther
peppermint oil with massage
Almond oilOther
Almond oil massage
| Study group | Role | What they receive |
|---|---|---|
| Peppermint oil | Experimental | Peppermint oil has an effect on menopausal symptoms Receives: Other: peppermint oil |
| Lemon oil | Experimental | Lemon oil has an effect on menopausal symptoms. Receives: Other: Lemon oil |
| almond oil | Placebo comparator | Almond oil has an effect on menopausal symptoms. Receives: Other: Almond oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Symptoms Evaluation Scale
The original name of the scale is Menopause Rating Scale (MRS). The menopausal symptom rating scale (MSDS) was developed by Schneider et al. (2002) to measure the severity of menopausal symptoms. It was adapted into Turkish by Gürkan (2005). Menopause symptom assessment scale (MSDS) consists of 11 items. It is a Likert-type scale, and each item has options such as "None (0)", "Mild (1)", "Moderate (2)", "Severe (3)" and "Very Severe (4)". The total score of the scale is calculated by calculating the scores given for each item. A minimum of 0 points and a maximum of 44 points can be obtained from the scale. The increase in the total score obtained from the scale indicates the increase in the severity of the complaints. The Cronbach Alpha coefficient of the scale is 0.84.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start27 Dec 2022
- Primary completion30 Jan 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AromatherapyStudies 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
- Model description
- Massage will be done for 4 weeks and 2 times a week (8 massages will be given to a person in total). Experimental groups: The researcher will add 2 drops of aromatic oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes. Peppermint oil will be used in the first experimental group, lemon oil in the second experimental group and only almond oil in the control group. The fragrance to be used before starting the application will be given to the women by giving them a sniff.Placebo Group: Hand and arm massage will be performed for 30 minutes by the researcher using only almond oil. Three groups will be formed from women with menopausal symptoms. 1st group will be given a massage with Mint, 2nd group Lemon, 3rd group (placebo group-almond oil) and menopausal symptoms, happiness, peace and aging anxiety symptoms will be evaluated between the groups. All groups will be pre-tested before the procedure. 4. At the end of the massage, the test will be repeated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HAFİZE DAĞ TÜZMEN, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677698
- Sponsor's protocol ID
- Karatayhfz
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farahani MA, Afsargharehbagh R, Marandi F, Moradi M, Hashemi SM, Moghadam MP, Balouchi A. Effect of aromatherapy on cancer complications: A systematic review. Complement Ther Med. 2019 Dec;47:102169. doi: 10.1016/j.ctim.2019.08.003. Epub 2019 Aug 5.
PubMed 31779991Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018 May;297(5):1145-1150. doi: 10.1007/s00404-018-4700-1. Epub 2018 Feb 3.
PubMed 29397442Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.
PubMed 26316239Parry BL. Depressive history as a major predictor of postmenopausal depressive symptoms. Menopause. 2022 Jul 1;29(7):763-764. doi: 10.1097/GME.0000000000002027. No abstract available.
PubMed 35728014Lee J, Han Y, Cho HH, Kim MR. Sleep Disorders and Menopause. J Menopausal Med. 2019 Aug;25(2):83-87. doi: 10.6118/jmm.19192. Epub 2019 Aug 5.
PubMed 31497577Bansal R, Aggarwal N. Menopausal Hot Flashes: A Concise Review. J Midlife Health. 2019 Jan-Mar;10(1):6-13. doi: 10.4103/jmh.JMH_7_19.
PubMed 31001050Cramer H, Peng W, Lauche R. Yoga for menopausal symptoms-A systematic review and meta-analysis. Maturitas. 2018 Mar;109:13-25. doi: 10.1016/j.maturitas.2017.12.005. Epub 2017 Dec 6.
PubMed 29452777Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
PubMed 30868921Kazemzadeh R, Nikjou R, Rostamnegad M, Norouzi H. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial. J Chin Med Assoc. 2016 Sep;79(9):489-92. doi: 10.1016/j.jcma.2016.01.020. Epub 2016 Jul 4.
PubMed 27388435Sanchez-Vidana DI, Ngai SP, He W, Chow JK, Lau BW, Tsang HW. The Effectiveness of Aromatherapy for Depressive Symptoms: A Systematic Review. Evid Based Complement Alternat Med. 2017;2017:5869315. doi: 10.1155/2017/5869315. Epub 2017 Jan 4.
PubMed 28133489Gurler M, Kizilirmak A, Baser M. The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial. Complement Med Res. 2020;27(6):421-430. doi: 10.1159/000507751. Epub 2020 Jun 9.
PubMed 32516765El Khoudary SR, Greendale G, Crawford SL, Avis NE, Brooks MM, Thurston RC, Karvonen-Gutierrez C, Waetjen LE, Matthews K. The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN). Menopause. 2019 Oct;26(10):1213-1227. doi: 10.1097/GME.0000000000001424.
PubMed 31568098Taşkın L, editör. Doğum ve kadın sağlığı hemşireliği. Genişletilmiş XIII. Baskı. Ankara: Akadmisyen Tıp Kitabevi; 2019. p. 671-687
Gözüyeşil E, Başer M. 2016.'' Menopozal dönemde yaşanan vazomotor yakınmaların günlük yaşam aktiviteleri üzerine etkisi'', Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 19(4):1-8.
Türkiye İstatistik Kurumu. İstatistiklerle kadın, 2019. Türkiye İstatistik Kurumu Haber Bülteni. Sayı: 33732 Yayın Tarihi: 06.03.2020 1-5.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menoupausal Symptoms and Aromatherapy
- ClinicalTrials.gov ID
- NCT05677698
- Acronym / sponsor ID
- Karatayhfz
- Conditions
- Aromatherapy
- Keywords
- aromatherapy, menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 10 Jan 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.
Aromatherapy is "highly distilled herbs distilled to take advantage of their therapeutic properties".
is the science of using concentrated essential oils or essences".Essential oils or essences are obtained from various parts of plants (root, leaves, flowers, bark, fruit) and used therapeutically for physical and psychological well-being. The fact that aromatherapy is a noninvasive procedure and its ease of use allows for widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These include topical (tap, compress, or bath), internal (mouthwash, vaginal, or anal suppository), oral (with capsules or reconstitution in honey, alcohol, or diluent), and inhalation (direct or indirect, with or without steam, inhalation). ). Essential oils, which can be applied in various ways, can directly reach the neocortex part of the brain through connections extending from the limbic system to the hypothalamus via scent.
Detailed description
As a result of the effect of aromatic oils on the central nervous system, relaxation, sedation or stimulating effects occur and the information flow reaching the brain with the stimulation of the central nervous system.
Thanks to this, the energy blockage in the body is broken and as a result, energy is released. With the balanced distribution of the energy flow to the relevant organs, the healing process is supported, and physical and mental well-being emerges . Aromatherapy is used in many health fields as well as women's health. Menopause is a process in which physiological, psychological and hormonal changes occur in the life of all women . The World Health Organization defines menopause as "the permanent cessation of menstruation with loss of ovarian activity" . In addition to physical symptoms such as hot flashes, sweating, headache, low libido, fatigue, sleep disorders, palpitations, which occur as a result of the decrease in estrogen and progesterone hormone secretion and its end over time, psychological symptoms such as anxiety, depression and mood disorders are frequently encountered . Due to the increase in the number of women in the menopausal period in the world, it is important to reduce menopausal complaints and improve women's health.Studies have shown that aromatherapy is a complementary method used in a wide variety of situations to reduce physiological and psychological symptoms . It is stated that menopausal symptoms decrease in women who smell lavender aroma during menopause . It is important that the symptoms seen during menopause, which is an important part of a woman's life, are reduced and that women can spend this process more comfortably. While the age at menopause is in the range of 50-51 years worldwide, it is reported that the age of menopause in our country is between the ages of 47-49 . From this point of view, women spend about one third of their lives during and after menopause. The trend towards traditional and complementary medicine is increasing day by day in our country. However, in addition to the widespread use of aromatherapy in the world, aromatherapy practices are not common in our country. Diluted and ready-to-use forms of aromatic oils are not only available in pharmacies and herbalists, but also a method that people are curious about and want to use. The fact that the cost of ready-to-use aromatic oils is cheaper than drugs and easily accessible will provide women with a treatment option in the light of new evidence in line with the conduct of the study. In studies in the literature, it is stated that lavender, rose, geranium, and citrus oils are massaged to women in the menopausal period and provide mental and physical relaxation. Therefore, in our study, the use of Peppermint and Lemon oils to reduce the symptoms of menopausal women and increase their psychosocial well-being. is planned. Peppermint (Mentha Piperita) oil has analgesic, immune system strengthening, antispasmodic, antipyretic, anti-nausea and vomiting, anesthetic, helps concentration, increases self-confidence and creative thoughts, and Lemon (Citrus Lemon) oil is analgesic, immune-enhancing, antipyretic. It is thought that it can help relieve the psychological and physiological complaints of women in the menopausal period due to its properties such as helping constipation, reducing nausea and vomiting, increasing sleep quality, relieving stress and antidepressant. For this reason, it is planned to use Peppermint and Lemon oils in our study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Massage will be done for 4 weeks and 2 times a week (8 massages will be given to a person in total). Experimental groups: The researcher will add 2 drops of aromatic oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes. Peppermint oil will be used in the first experimental group, lemon oil in the second experimental group and only almond oil in the control group. The fragrance to be used before starting the application will be given to the women by giving them a sniff.Placebo Group: Hand and arm massage will be performed for 30 minutes by the researcher using only almond oil. Three groups will be formed from women with menopausal symptoms. 1st group will be given a massage with Mint, 2nd group Lemon, 3rd group (placebo group-almond oil) and menopausal symptoms, happiness, peace and aging anxiety symptoms will be evaluated between the groups. All groups will be pre-tested before the procedure. 4. At the end of the massage, the test will be repeated.
| Arm | Type | Receives |
|---|---|---|
| Peppermint oil | Experimental | Other: peppermint oilPeppermint oil has an effect on menopausal symptoms |
| Lemon oil | Experimental | Other: Lemon oilLemon oil has an effect on menopausal symptoms. |
| almond oil | Placebo comparator | Other: Almond oilAlmond oil has an effect on menopausal symptoms. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experiencing at least 1 of the menopausal symptoms (self-report),
- No respiratory disease such as asthma, bronchitis (self-report),
- Not allergic to the oils to be used (self-report),
Key exclusion criteria (2 listed)
- Not experiencing menopausal complaints,
- Those who do not want to participate in the research
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 |
|---|---|---|
| Lemon oilLemon oil with massage | Other | Lemon oil |
| peppermint oilpeppermint oil with massage | Other | Peppermint oil |
| Almond oilAlmond oil massage | Other | almond oil |
Primary outcome
Menopause Symptoms Evaluation Scale
Time frame: 1 year
The original name of the scale is Menopause Rating Scale (MRS). The menopausal symptom rating scale (MSDS) was developed by Schneider et al. (2002) to measure the severity of menopausal symptoms. It was adapted into Turkish by Gürkan (2005). Menopause symptom assessment scale (MSDS) consists of 11 items. It is a Likert-type scale, and each item has options such as "None (0)", "Mild (1)", "Moderate (2)", "Severe (3)" and "Very Severe (4)". The total score of the scale is calculated by calculating the scores given for each item. A minimum of 0 points and a maximum of 44 points can be obtained from the scale. The increase in the total score obtained from the scale indicates the increase in the severity of the complaints. The Cronbach Alpha coefficient of the scale is 0.84.
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 1 Mar 2023.
- Background: PubMed 31779991Farahani MA, Afsargharehbagh R, Marandi F, Moradi M, Hashemi SM, Moghadam MP, Balouchi A. Effect of aromatherapy on cancer complications: A systematic review. Complement Ther Med. 2019 Dec;47:102169. doi: 10.1016/j.ctim.2019.08.003. Epub 2019 Aug 5.
- Background: PubMed 29397442Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018 May;297(5):1145-1150. doi: 10.1007/s00404-018-4700-1. Epub 2018 Feb 3.
- Background: PubMed 26316239Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.
- Background: PubMed 35728014Parry BL. Depressive history as a major predictor of postmenopausal depressive symptoms. Menopause. 2022 Jul 1;29(7):763-764. doi: 10.1097/GME.0000000000002027. No abstract available.
- Background: PubMed 31497577Lee J, Han Y, Cho HH, Kim MR. Sleep Disorders and Menopause. J Menopausal Med. 2019 Aug;25(2):83-87. doi: 10.6118/jmm.19192. Epub 2019 Aug 5.
- Background: PubMed 31001050Bansal R, Aggarwal N. Menopausal Hot Flashes: A Concise Review. J Midlife Health. 2019 Jan-Mar;10(1):6-13. doi: 10.4103/jmh.JMH_7_19.
- Background: PubMed 29452777Cramer H, Peng W, Lauche R. Yoga for menopausal symptoms-A systematic review and meta-analysis. Maturitas. 2018 Mar;109:13-25. doi: 10.1016/j.maturitas.2017.12.005. Epub 2017 Dec 6.
- Background: PubMed 30868921Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
- Background: PubMed 27388435Kazemzadeh R, Nikjou R, Rostamnegad M, Norouzi H. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial. J Chin Med Assoc. 2016 Sep;79(9):489-92. doi: 10.1016/j.jcma.2016.01.020. Epub 2016 Jul 4.
- Background: PubMed 28133489Sanchez-Vidana DI, Ngai SP, He W, Chow JK, Lau BW, Tsang HW. The Effectiveness of Aromatherapy for Depressive Symptoms: A Systematic Review. Evid Based Complement Alternat Med. 2017;2017:5869315. doi: 10.1155/2017/5869315. Epub 2017 Jan 4.
- Background: PubMed 32516765Gurler M, Kizilirmak A, Baser M. The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial. Complement Med Res. 2020;27(6):421-430. doi: 10.1159/000507751. Epub 2020 Jun 9.
- Background: PubMed 31568098El Khoudary SR, Greendale G, Crawford SL, Avis NE, Brooks MM, Thurston RC, Karvonen-Gutierrez C, Waetjen LE, Matthews K. The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN). Menopause. 2019 Oct;26(10):1213-1227. doi: 10.1097/GME.0000000000001424.
- World Health Organization (1981). Research on the menapouse. Available date: 16.08.2022Link provided by the sponsor.
- 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.
HAFİZE DAĞ TÜZMEN principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemon oil, peppermint oil and Almond oil in people with Aromatherapy, run by KTO Karatay 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 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 1 Mar 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?
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?
Menopause Symptoms Evaluation Scale (time frame: 1 year). 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 NCT05677698, which also lists 24 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 1 Mar 2023.