Effect of Lavender Versus Primrose Oil on Menopause Symptom

NCT05988242 | Completed

• 1 other identifier: Lavender and Primrose
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

there is a scanty of researches which integrate to investigate the comparing effect of evening primrose oil and lavender as the essential oil that affects on menopausal vasomotor symptoms especially hot flashes and night sweet Therefore, the current study is expected to contribute to the knowledge and practice regarding the effect of lavender versus primrose oil on hot flashes and night sweat in menopausal women.

Conditions

Menopause Syndrome

Keywords

Hot Flashes; Sweat; Menopause; Lavandula; Primula

Outcome Measures

Primary Outcomes (3)

• frequency of hot flashes among menopausal women.

  it will be assessed by Daily Hot Flash Diary: It is a selfreport dairy in which participants recorded how many hot flashes they experienced on a daily basis. Hot flashes throughout a 7-day period were added to produce a weekly hot flash frequency score

  Before intervention, 4 week after intervention, 8 week after intervention

• severity of hot flashes among menopausal women

  it will be assessed by Daily Hot Flash Diaryas well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3 severe). the number of hot flashes reported in each severity level was used to calculate the daily severity score, the total number of daily severity scores over the course of seven days was used to determine the hot flash severity index. The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes

  Before intervention, 4 week after intervention, 8 week after intervention

• to To what extent hot flash and night sweet are a problem

  This tool is standardized tool to measure the extent to which hot flash and night sweet are a problem, it is a subscale of the Hot Flush Rating Scale (HFRS) this validated self-report measure has three questions using 10-point Likert scales to rate the extent to which HFNS are problematic, distressing, and the cause of interference in daily life. Problem rating is calculated as the mean of the three questions, with higher scores indicating more problematic

  Before intervention, 4 week after intervention, 8 week after intervention

Secondary Outcomes (1)

• Hot Flash Related Daily Interference

  Before intervention, 4 week after intervention, 8 week after intervention

Study Arms (3)

primrose oil

EXPERIMENTAL

primrose oil

Other: Primrose oil

lavender oil

EXPERIMENTAL

lavender oil

Other: Lavender oil

the placebo group

PLACEBO COMPARATOR

took the same bottle of oil which didn't contain the active substances but have the same shape, same oder, same color.

Other: placcebo

Interventions

Primrose oil OTHER

group A will take primrose oil

primrose oil

Lavender oil OTHER

group B will take lavender oil

lavender oil

placcebo OTHER

this is the comparator group who will take the same bottle of oil which dosnt contain the active substances but have the sampe shape, same oder, same color

the placebo group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• can read and write
• experienced amenorrhea for \> 6 months
• mild or moderate-to-severe hot flashes at least twice daily
• normal blood pressure
• normal kidney and liver function
• no abnormal vaginal bleeding
• no sensitivity to herbal substances

You may not qualify if:

• Women with serious disease such as kidney, liver, seizure and allerg
• use of hormonal medications or herbal treatment in the preceding 2 months for treatment of hot flushes or night sweet

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of nursinf

Cairo, 12519, Egypt

Location

Related Publications (9)

• Kazemi F, Masoumi SZ, Shayan A, Oshvandi K. The Effect of Evening Primrose Oil Capsule on Hot Flashes and Night Sweats in Postmenopausal Women: A Single-Blind Randomized Controlled Trial. J Menopausal Med. 2021 Apr;27(1):8-14. doi: 10.6118/jmm.20033.

  PMID: 33942584 BACKGROUND

• Farzaneh F, Fatehi S, Sohrabi MR, Alizadeh K. The effect of oral evening primrose oil on menopausal hot flashes: a randomized clinical trial. Arch Gynecol Obstet. 2013 Nov;288(5):1075-9. doi: 10.1007/s00404-013-2852-6. Epub 2013 Apr 27.

  PMID: 23625331 BACKGROUND

• Reddi KK. Human granulocyte ribonuclease. Biochem Biophys Res Commun. 1976 Feb 23;68(4):1119-25. doi: 10.1016/0006-291x(76)90312-0. No abstract available.

  PMID: 5077 BACKGROUND

• Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011.

  PMID: 30098758 BACKGROUND

• Carreiras M, Seghier ML, Baquero S, Estevez A, Lozano A, Devlin JT, Price CJ. An anatomical signature for literacy. Nature. 2009 Oct 15;461(7266):983-6. doi: 10.1038/nature08461.

  PMID: 19829380 BACKGROUND

• Mehrpooya M, Rabiee S, Larki-Harchegani A, Fallahian AM, Moradi A, Ataei S, Javad MT. A comparative study on the effect of "black cohosh" and "evening primrose oil" on menopausal hot flashes. J Educ Health Promot. 2018 Mar 1;7:36. doi: 10.4103/jehp.jehp_81_17. eCollection 2018.

  PMID: 29619387 BACKGROUND

• Green MR, Pastewka JV. The cationic carbocyanine dyes Stains-all DBTC, and Ethyl-Stains-all, DBTC-3,3',9 triethyl. J Histochem Cytochem. 1979 Mar;27(3):797-9. doi: 10.1177/27.3.90067.

  PMID: 90067 BACKGROUND

• Tsai J, Chung YC, Chen FP, Yeh ML. [Effect of Aromatherapy on Menopausal Symptoms, Heart Rate Variability, and Sleep Quality in Women]. Hu Li Za Zhi. 2020 Feb;67(1):44-54. doi: 10.6224/JN.202002_67(1).07. Chinese.

  PMID: 31960396 RESULT

• Kazemzadeh 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.

  PMID: 27388435 RESULT

MeSH Terms

Conditions

Hot Flashes

Interventions

evening primrose oil; lavender oil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lamiaa Saad, lecturer

  faculty of nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Regarding the nature of the intervention it will be double blind as the women will not know which intervention will take and the randomization of the groups will be done by person other than the researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of maternal and newborn health nursing

Model Details: Parallel randomized controlled trial will be used to fulfill the aim of proposed study. The randomized control trial (RCT) is a trial in which subjects are randomly assigned to one of two or more groups: the intervention (group A) who will receive evening primrose oil, the intervention (group B) who will receive lavender oil, the third group ( C) who will receive placebo (Spieth et al, 2016).

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: March 20, 2022
• Primary Completion: April 21, 2023
• Study Completion: July 20, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: four month
• Access Criteria: will be published on magazine

Locations

EG (1)