The aim of study: to compare the effect of urticaria dioica and acupuncture on hot flash and other monopausal symptoms. Design: Randomized, double blind, placebo controlled, parallel, phase 3 trial. Methods: 45 to 60 year old menopausal patients who met the inclusion criteria will be randomly assigned to one of four study groups and treated for 7 weeks. The number and severity of hot flushes per day according to the patient's daily report, the severity of menopausal symptoms according to the Menopausal Rating Scale questionnaire and level FSH, estradiol, LH will be compared before and after the study in all four groups.
A. study population: post-menopausal women aged 45 to 60 with hot flashes.
The main inclusion criteria :1-post-menopausal women aged 45-60 years who sign the written consent.
The main outcomes of the study: 1- History of hysterectomy or oophorectomy 2- Taking anticancer therapies 3- suffering from estrogen-related cancers over the past 5 years. 4. History of mental disorder 5- Hyperthyroidism or hypothyroidism 6. Taking any medication for hot flashes in the past 8 weeks 7- Endometrial thickness over 12 mm in uterine ultrasonography 8-Vaginal bleeding with unknown origin in the last 6 months
o Sample size 68
B) Intervention or intervention
nettle, acupuncture, combination of both.
C-intervention time
7 weeks.
D-Primary outcome. Or outcomes
• Number and severity of hot flushes per day
• Severity of other symptoms of menopause
• FSH, estradiol, LH
General information
Acronym
Nettle and acupuncture in hot flashes
IRCT registration information
IRCT registration number:IRCT201707017265N10
Registration date:2017-08-13, 1396/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Urtica dioica, acupuncture and their combined therapy on hot flashes during menopause
Public title
Treatment of menopause by Nettle and acupuncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes; Age 45-60 years old; Approval for treatment of hot flashes and consent to participate in the plan.
Exclusion criteria: History of hysterectomy or oophorectomy; Anticancer therapies due to malignancy; History of estrogen-dependent cancers over the past five years; History of allergy to urticaria or acupuncture; History of known psychiatric disorders; Hyperthyroidism or hypothyroidism; Conditions and physical illnesses that are not suitable for this study: Cardiovascular disease (coronary artery disease, cerebrovascular disease and thromboembolic disorders) uncontrolled Hypertension or diabetes, kidney or liver failure. 8- use of anticoagulants; Taking any medication for hot flashes such as HRT and SSRI in the past eight weeks; Endometrial thickness over 12 mm in uterine ultrasonography; Vaginal bleeding with unknown origin in the past 6 months; Complications due to drug therapy or acupuncture.
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research, Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Postal code
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.MUMS.REC.1396.144
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Level of FSH, estradiol, LH
Timepoint
Before the study and at week 7
Method of measurement
blood test
2
Description
Severity of menopausal symptoms
Timepoint
Before the intervention, week 4 and 7
Method of measurement
Menopausal Rating Scale questionnaire
3
Description
Number and severity of hot flashes per day
Timepoint
One week before the study and at weeks 4 and 7
Method of measurement
Patient Daily Report
Secondary outcomes
empty
Intervention groups
1
Description
Acupuncture, two sessions/week from week 1 to 4, and one session/week through weeks 5 to 7 + nettle in the form of Urtidin tablet 150 mg, 3 times/ day for 7 weeks.
Category
Treatment - Other
2
Description
Acupuncture, two sessions from week one to fourth and one session at week five through seventh + placebo nettle, once every three weeks for seven weeks.
Category
Other
3
Description
Acupuncture sham, two sessions from week one to fourth, and one session in the fifth to seventh week + nettle in the form of a 150 mg orthidine tablet every three times for seven weeks.
Category
Other
4
Description
Acupuncture sham, two sessions from week one to fourth and one session at week five to seven + placebo nettle three times a day for seven weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Acupuncture clinic of Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Gynecology Clinic of Imam Reza Hospital
Full name of responsible person
Dr. Salmeh Dadgar
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of research office, MUMS central office, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Clinical Ph.D./Assistant professor
Other areas of specialty/work
Street address
Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3882 9279
Fax
Email
azizih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roshanak Salari
Position
Ph.D. in Pharmacy / Assistant Professor
Other areas of specialty/work
Street address
School of traditional and complementary medicine, University campus, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3882 9279
Fax
Email
salarir@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional and Complementary Medicine
Full name of responsible person
Dr Raheleh kargozar
Position
Ph.D. student of Traditional Medicine
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
kargozarr931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)