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Comparative efficacy of Nettle (Urtica Dioica) with Combined Oral Contraceptive pills (COCs), on Clinical and Paraclinical Symptoms of Polycystic Ovary Syndrome (PCOS): A Triple Blind Randomized Controlled Trial

Protocol summary

Study aim
Comparing the effects of nettle extract with combined oral contraceptives (COCs) on clinical and paraclinical symptoms of polycystic ovary syndrome.
Design
controlled clinical trial, phase 3, with two-parallel groups, triple-blind
Settings and conduct
This study will be conducted in the clinics of the University of Medical Sciences and the Faculty of Traditional Medicine. The random assignment sequence will be determined by a person not involved in the study using G-Power software. To conceal the allocation of drug or placebo, it will be placed in opaque, sequentially numbered envelopes. Qualified people will be placed in two intervention and control groups using the random block method with a block size of 6 and with a 1:1 allocation sequence.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 18-40 years who have been diagnosed with PCOS according to the Rotterdam criteria for the diagnosis of PCOS and are literate, do not use hormonal contraceptives and do not want to get pregnant. Exclusion criteria: relative and absolute contraindications of LD pills, undergoing infertility treatment, surgery on the ovary, sensitivity to nettle, disorders leading to hyperandrogenism.
Intervention groups
Intervention group: nettle extract capsules (containing flavonoids, tannins and sterols) in the number of 30 capsules daily for use in each cycle and control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) in the number of 21 capsules along with 9 capsules Contains an ineffective substance for use in a 30-day cycle, which will be placed in the same package for use in three cycles separately.
Main outcome variables
Average serum level of DHEA and total testosterone; Average score of hirsutism

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110606006709N25
Registration date: 2023-05-18, 1402/02/28
Registration timing: prospective

Last update: 2023-05-18, 1402/02/28
Update count: 0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Nettle (Urtica Dioica) with Combined Oral Contraceptive pills (COCs), on Clinical and Paraclinical Symptoms of Polycystic Ovary Syndrome (PCOS): A Triple Blind Randomized Controlled Trial
Public title
Comparing the effect of nettle extract with COCs on the improvement of clinical and paraclinical symptoms of polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirming the diagnosis of PCOS according to the Rotterdam criteria (clinical or biochemical hyperandrogenism, menstrual cycle disorders or polycystic ovary ultrasound signs) Age 18 to 40 years Being literate in reading and writing BMI between 18.5 and 30 Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months Not wanting to get pregnant
Exclusion criteria:
Relative and absolute contraindications of LD tablets (having blood pressure above 14/9, smoking and alcohol use, pregnancy or breastfeeding, alcohol and smoking use, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.) Women undergoing infertility treatment at the time of study. Previous surgery on one or both ovaries. Allergy to nettle Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.)
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be placed in two intervention and control groups using a random block method with a block size of 6 and with a 1:1 allocation sequence. The allocation sequence will be determined by a person not involved in the study using G-Power software, placed in consecutively numbered opaque envelopes to conceal drug or placebo allocation, and prepared according to the allocation sequence by The person not involved in the research will be done from number 1 to 60.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Medicines (nettle extract and LD) will be prepared by the pharmaceutical company in a completely similar form in terms of shape, color and smell. The participant, researcher, data analyst will be unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.TAZMED.REC.1402.113

Health conditions studied

1

Description of health condition studied
Clinical and paraclinical symptoms of polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Serum levels of DHEA and total testosterone
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
By ELISA method in the central laboratory

2

Description
Average score of hirsutism
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Ferriman–Gallwey scale

Secondary outcomes

1

Description
Normalization of menstrual cycles
Timepoint
Before the intervention, one month, two months, and three months after the intervention
Method of measurement
Questionnaire made by the researcher and Higham's chart

2

Description
Serum level of fasting blood sugar
Timepoint
Before the start of the intervention and and 3 months after the intervention
Method of measurement
By spectrophotometric method in the central laboratory

3

Description
Serum levels of gonadotropins (FSH and LH)
Timepoint
Before the start of the intervention and and 3 months after the intervention
Method of measurement
By ELISA method in the central laboratory

Intervention groups

1

Description
Nettle extract capsules (containing flavonoids, tannins and sterols) in the number of 30 capsules, one daily for three cycles, which will be prepared and packaged by Sina Navandish Company.
Category
Treatment - Drugs

2

Description
Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), in the number of 21 capsules along with 9 capsules containing an ineffective substance to be consumed in a cycle of 30 capsules per day for three cycles, which will be prepared and packaged by Sina Navandish Company .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Faride Majdi
Street address
Al-Zahra hospital, Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahospital@tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Faride Majdi
Street address
Taleghani hospital, Rah-Ahan square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3442 4423
Email
taleghani.hos@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research department, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Faride Majdi
Position
Msc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati St
City
Tabriz
Province
East Azarbaijan
Postal code
5135963777
Phone
+98 41 3523 0741
Email
faridemajdi211@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
shahnazimahnaz@ gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faride Majdi
Position
Msc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati St, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
faridemajdi211@gmail.com

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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