Protocol summary

Study aim
Determining the effect of "Hydroalcoholic Extract of Heracleum parsicum" on hot flashes in menopausal women
Design
Triple blind randomized clinical trial with two intervention and control groups on 80 menopausal women. Randomization is by randomly assigned blocking (blocks with size four).
Settings and conduct
Participants were selected from menopausal women with symptoms of hot flashes referred to Mashhad health centers and after completing the written consent form, personal details and menstruation, daily hot flashes registration form and night sweats registration form for daily hot flashes and night sweats registration for up to 4 weeks. To confirm that a person has hot flashes, people are screened for 2 weeks and if they have 5 moderate or severe hot flashes per day, they are included in the study.Then offer the same medicine capsules to the two groups to take daily for 4 weeks Data before the intervention and data 2 and 4 weeks after the intervention are analyzed with SPSS software version 16.Blinding involves the researcher, the outcome evaluator, the participant, and the data analyst
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 12 months after the last normal menstruation or FSH more than 40 and a maximum of ten year after the last normal menstruation, healthy Pap smear , do not use agents that reduce hot flashes, no chronic diseases Exclusion criteria: Major changes in diet and physical activity pattern, use of measures to reduce hot flashes during the study, not filling out the hot flashes questionnaire for 3 days or more One week, not taking the drug for 2 days or more
Intervention groups
Individuals are randomly divided into two treatment groups. The control group received Avisel 500 mg capsules and the intervention group received 500 mg Golpar capsules once a day for 4 weeks.
Main outcome variables
Duration, severity and frequency of hot flashes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220102053592N1
Registration date: 2022-06-18, 1401/03/28
Registration timing: prospective

Last update: 2022-06-18, 1401/03/28
Update count: 0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Seyedeh Faezeh Shajiee Jazin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5656 3346
Email address
shajieejf981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Heracleum persicum hydroalcoholic extract on hot flashes in menopausal women
Public title
the effect of Heracleum persicumon hot flashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Mashhad Literacy for reading and writing Phone number to call At least 12 months after the last normal menstruation or FSH> 40 and a maximum of one year after the last normal menstruation Healthy Pap smear: if the Pap smear is Liquid based from 5 years ago and the traditional Pap smear is from 3 years ago Complaints of hot flashes: on average during 2 weeks of screening, having moderate or severe hot flashes 5 or more times a day Not receiving estrogen or progesterone for the past three months No spotting in the past year Do not use tobacco (cigarettes, hookah and drugs) and alcohol No tragic events in life in the last 6 months: Death of spouse, children or close family members, severe illness of family members, major change in employment and life, dismissal or unemployment of self or spouse Severe family dispute or divorce Do not use medications to reduce the symptoms of hot flashes for the past 1 month: Hormonal contraceptives, venlafaxine, paroxytin, fluoxetine, gabapentin, clonidine, vitamin E supplements, bromocriptine, oral naloxone, veralipride, yoga, acupuncture, citalopram, sertraline, pre-gabapentin, relaxation techniques No chronic diseases: Cardiovascular, liver disorders, skin diseases, thyroid disorders Lack of sensitivity to Heracleum persicum: Includes any changes and skin allergies and sensitivity to sunlight Do not use medicinal plants containing phytoestrogens: including soybeans, flaxseed, licorice, fenugreek, fennel, hops, sage, red clover, black cohosh
Exclusion criteria:
Major changes in nutrition and physical activity patterns: Starting exercise programs Use of medicinal plants containing phytoestrogens during the study: including soybeans, flaxseed, licorice, fenugreek, fennel, hops, sage, red clover, black cohosh use medications to reduce the symptoms of hot flashes for the past 1 month: Hormonal contraceptives, venlafaxine, paroxytin, fluoxetine, gabapentin, clonidine, vitamin E supplements, bromocriptine, oral naloxone, veralipride, yoga, acupuncture, citalopram, sertraline, pre-gabapentin, relaxation techniques Do not fill out the hot flush questionnaire for 3 days or more in a week Do not take the drug for 2 days or more Occurrence of symptoms of allergy to heracleum persicum during the study: includes any changes and skin sensitivity and sensitivity to sunlight, including any changes and skin sensitivity and sensitivity to sunlight
Age
From 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block stratified random allocation is used. In the first stage, based on the BMI index, the samples are placed in three classes: BMI≥30, BMI = 25-29.9 and BMI <25. Then, inside the classes, the samples are assigned to research groups A or B by randomly allocating blocks with quadruple blocks using PASS statistical software. To hide the allocation, sealed envelopes are numbered in order. This form is opened according to the order of entry of eligible participants to study the relevant envelope and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is triple blind; This means that the participant, researcher and outcome evaluator and data analyst are unaware of the allocation of study groups and the same capsules in terms of color, odor and shape for both groups (drug and placebo) in the same box with a code label. (A and B coded by the pharmacologist) are used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street, Mashhad, Khrasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.002

Health conditions studied

1

Description of health condition studied
Hot flashes
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Duration of hot flashes
Timepoint
At the beginning of the study and 2 and 4 weeks after the intervention
Method of measurement
Daily hot flush registration form

2

Description
Intensity of hot flashes
Timepoint
At the beginning of the study and 2 and 4 weeks after the intervention
Method of measurement
Daily hot flush registration form

3

Description
Frequent flushing
Timepoint
At the beginning of the study and 2 and 4 weeks after the intervention
Method of measurement
Daily hot flush registration form

Secondary outcomes

1

Description
Intensity of night sweats
Timepoint
At the beginning of the study and 2 and 4 weeks after the intervention
Method of measurement
Night sweat registration form

2

Description
Frequent night sweats
Timepoint
At the beginning of the study and 2 and 4 weeks after the intervention
Method of measurement
Night sweat registration form

Intervention groups

1

Description
Intervention group: To the intervention group, capsules containing 500 mg of hydroalcoholic extract of Angelica baccarat Herbarium E1259-FUMH, prepared in the laboratory of Mashhad School of Traditional Medicine, are given one orally daily for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: To the control group, capsules containing 500 mg of oral Avisel powder prepared in the laboratory of Mashhad School of Traditional Medicine will be given as one drop orally daily for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad health centers
Full name of responsible person
Faezeh Shajieej
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
shajieejf981@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahboubeh Firoozi
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
firoozimah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Shajieej
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
shajieejf981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahboubeh Firoozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
firoozimah@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Shajieeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
shajieejf981@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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