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Evaluation of the effect of a combination product based on Vitex agnus castus herb compared to Dydrogesterone drug on oligomenorrhea caused by polycystic ovary syndrome: A randomized, triple-blind, clinical trial

Protocol summary

Study aim
*A) General Objective: To determine the efficacy of a combination product based on Chasteberry (Vitex agnus-castus*) compared to Dydrogesterone on oligomenorrhea caused by Polycystic Ovary Syndrome (PCOS)
Design
Patients will be randomly assigned to two groups (control and intervention) using block randomization in blocks of four. Randomization will be performed using a random allocation list generated by Excel. The study will be conducted in a triple-blind manner (blinding the patient, the primary investigator, and the statistical analyst). To ensure blinding, Dydrogesterone and the herbal medication will be randomly assigned codes A and B; these codes will only be revealed after the statistical analysis is completed to prevent performance and information bias. The control group will receive 10 mg of Dydrogesterone, while the intervention group will receive a herbal capsule formulated from Chasteberry (including Vitex agnus-castus* seeds, Daucus carota seeds, and Mentha pulegium leaves). Furthermore, Dr. Samira Eghbali, a faculty member at the School of Pharmacy, Birjand University of Medical Sciences, is designated to handle the coding of medications and patients to maintain the triple-blind integrity of the study
Settings and conduct
Gynecology clinics at Valiasr Hospital and Rouyesh Infertility Center, Birjand, during 2026-2027.
Participants/Inclusion and exclusion criteria
Women18-45age with pco
Intervention groups
chemical drog and herbal drog
Main outcome variables
Incidence of menstrual bleeding and regularization of cycles.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251224068427N1
Registration date: 2026-04-15, 1405/01/26
Registration timing: prospective

Last update: 2026-04-15, 1405/01/26
Update count: 0
Registration date
2026-04-15, 1405/01/26
Registrant information
Name
Fahimeh Zangooie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1753
Email address
fzangooi@bums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2027-10-23, 1406/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of a combination product based on Vitex agnus castus herb compared to Dydrogesterone drug on oligomenorrhea caused by polycystic ovary syndrome: A randomized, triple-blind, clinical trial
Public title
Comparison of the efficacy of a Chasteberry-based herbal medicine with Dydrogesterone in the treatment of Polycystic Ovary Syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18 to 45 years with PCOS presenting with symptoms of oligomenorrhea to the gynecology clinics of Valiasr Hospital and Rouyesh Infertility Center in Birjand, who have been diagnosed with PCOS by a gynecologist using the Rotterdam criteria, will be included. Malignancies, pregnancy, and other hormonal causes of oligomenorrhea must be ruled out at baseline, ensuring that oligomenorrhea is solely due to PCOS. Furthermore, patients who are reluctant to use conventional chemical drugs or invasive/semi-invasive procedures, and for whom the gynecologist deems traditional medicine treatment and a 12-week observation period without conventional interventions safe and non-detrimental, will be voluntarily referred to the researcher. Participants will enter the study after providing informed consent.
Exclusion criteria:
1. Co-morbid diabetes, dyslipidemia, or hypertension.2. Presence of treated or clinical hyper/hypothyroidism.3. Co-existing hyper/hypoprolactinemia.4. Concurrent cardiac, hepatic, renal, or adrenal diseases.5. Presence of Cushing's syndrome.6. Use of ovulation-inducing drugs within the last three months.7. Use of insulin-stimulating medications within the last three months.8. Pregnant or breastfeeding women with infants under 6 months of age.9. Women planning to become pregnant within the next three months.10. Patient's withdrawal of consent to continue treatment.11. Occurrence of allergic reactions to the medications used in the study, particularly to the Apiaceae (Umbelliferae) family.
Age
From 18 years old to 45 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
Patients will be randomly assigned to two groups(control and intervention) using block randomization in blocks of four. Randomization will be performed using a random allocation list generated by Excel. The study will be conducted in a triple-blind manner (blinding the patient, the primary investigator, and the statistical analyst). To ensure blinding, Dydrogesterone and the herbal medication will be randomly assigned codes A and B; these codes will only be revealed after the statistical analysis is completed to prevent performance and information bias. The control group will receive 10 mg of Dydrogesterone, while the intervention group will receive a herbal capsule formulated from Chasteberry (including Vitex agnus-castus* seeds, Daucus carota seeds, and Mentha pulegium leaves). Furthermore, Dr. Samira Eghbali, a faculty member at the School of Pharmacy, Birjand University of Medical Sciences, is designated to handle the coding of medications and patients to maintain the triple-blind integrity of the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted in a triple-blind manner (blinding the patient, the primary investigator, and the statistical analyst). To ensure blinding, Dydrogesterone and the herbal medication will be randomly assigned codes A and B; these codes will only be revealed after the statistical analysis is completed to prevent performance and information bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences.
Street address
ghaffari ave.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2026-03-09, 1404/12/18
Ethics committee reference number
IR.BUMS.REC.1404.538

Health conditions studied

1

Description of health condition studied
Polycystic Ovary Syndrome (PCOS).
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
incidence of menstrual bleeding and regularization of cycles.
Timepoint
THREE menstrua cycles
Method of measurement
The study participants will be divided into two groups of 30: Group A (herbal intervention) and Group B (Dydrogesterone 10 mg). *Group A will receive an herbal formulation based on Aslaq (comprising Daucus carota* seeds, Mentha pulegium, and Vitex agnus-castus), with the dosage adjusted according to Persian Medicine (PM) pharmacopeia, administered in two divided doses for three weeks (starting from day 7 of the menstrual cycle). *Group B will be treated with Dydrogesterone (10 mg/day) during the last ten days of their menstrual cycle. The intervention in both groups will be repeated for three consecutive menstrual cycles. A follow-up will be conducted in the fourth month (without medication) to evaluate the incidence and regularity of menstruation. The Higham Chart (Pictorial Blood Loss Assessment Chart, PBAC) will be utilized to determine the volume of menstrual bleeding

Secondary outcomes

1

Description
Menstrual bleeding volume, duration, and cycle length are considered *secondary outcomes. The changes in FSH, LH, Prolactin, TSH, Free Testosterone levels, and the LH/FSH ratio will be assessed and analyzed at both baseline and the end of the intervention. Furthermore, clinical improvements in hyperandrogenism symptoms, including acne and hirsutism (evaluated using the Ferriman-Gallwey score), will be recorded at the beginning and end of the study. Patient satisfaction with the treatment will be assessed at the end of the third month using the Visual Analogue Scale (VAS). Additionally, potential adverse drug reactions (ADRs) will be monitored and documented via a structured checklist
Timepoint
Three menstrual cycles per patient.
Method of measurement
The changes in *FSH, LH, Prolactin, TSH, Free Testosterone levels, and the LH/FSH ratio will be analyzed at baseline and at the end of the intervention. Furthermore, clinical improvements in hyperandrogenism-related symptoms, specifically acne and hirsutism (evaluated via the Modified Ferriman-Gallwey (mFG) score), will be assessed at the beginning and end of the study. Patient satisfaction with the treatment will be measured at the end of the third month using the Visual Analogue Scale (VAS). Potential adverse drug reactions will be monitored and recorded using a structured checklist.Statistical Analysis:Qualitative data will be described using frequency tables, while quantitative data will be presented as mean ± standard deviation (SD) or median (interquartile range, IQR). Data normality will be assessed using the Kolmogorov-Smirnov (K-S) test. For the comparison of qualitative variables, the Chi-square test or Fisher's exact test will be employed. To compare quantitative data between the two groups, the Independent T-test or Mann-Whitney U test will be utilized. If the sample size is sufficient, Analysis of Covariance (ANCOVA) or logistic regression will be used to control for confounding factors, depending on the nature of the dependent variable. All statistical analyses will be performed using SPSS software (version 22), with a significance level of p < 0.05

Intervention groups

1

Description
Intervention group:30 Women aged 18 to 45 years with *Polycystic Ovary Syndrome (PCOS) who will receive herbal treatment based on *Vitex agnus-castus* for three menstrual cycles.for 21 days in each cycle, excluding the menstrual period.
Category
Treatment - Drugs

2

Description
Intervention group: 30 women aged 18 to 45 years with *PCOS who will receive chemical treatment with Dydrogesterone (10 mg) for three menstrual cycles, administered during the last ten days of each cycle.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The Gynecology Clinics of *Vali-e-Asr Hospital
Full name of responsible person
dr. hossein dehghani
Street address
ghaffari ave.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3162 2501
Fax
+98 56 3204 8321
Email
webda@bums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
dr. yoosefi
Street address
ghaffari ave.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
1
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
Birjand University of Medical Sciences
Full name of responsible person
fahimeh zangooei
Position
resident in PHD of persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
ghaffari ave.
City
birjand
Province
South Khorasan
Postal code
9717635861
Phone
+98 915 860 9682
Email
Fzangooi62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mahdi Eslami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
ghaffari
City
birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3238 1498
Email
eslami.m@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
fahimeh zangooei
Position
resident of PHD of persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
ghaffari
City
birjand
Province
South Khorasan
Postal code
9717635861
Phone
+98 915 860 9682
Email
Fzangooi62@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to confidentiality requirements
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be made available in the associated
When the data will become available and for how long
Data will be available following the completion of the clinical trial and subsequent publication of the result
To whom data/document is available
Researchers and investigators
Under which criteria data/document could be used
To facilitate future clinical trials While maintaining document confidentiality
From where data/document is obtainable
DR. Fahimeh Zangooei
What processes are involved for a request to access data/document
Data requests may be directed to Dr. Zangooei through email. Access will be granted to authorized researchers upon successful academic identity verification
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