Investigating the therapeutic effects of HABES herbal syrup on abnormal uterine bleeding in women with hypermenorrhea

To evaluate and compare the therapeutic effects of HABES herbal syrup and Golnar capsule on abnormal uterine bleeding in women with hypermenorrhea, in comparison with an active control (tranexamic acid).

This study is a randomized, controlled, single-center clinical trial with three parallel arms, in which participants are allocated using permuted block randomization and the study is conducted as single-blind.

This study is conducted at the Royā Infertility Treatment Center (ACECR), Qom, Iran. Eligible participants are enrolled after written informed consent and randomly assigned to study groups, with all interventions and assessments performed according to the study protocol at the same center.

Women aged 20–55 years diagnosed with menorrhagia (hypermenorrhea) due to uterine fibroid or endometrial polyp who are candidates for hysteroscopy and have menstrual bleeding lasting more than seven days with abnormal uterine bleeding at irregular intervals will be eligible for inclusion in this study. Women with gastrointestinal disorders or any chronic disease requiring long-term treatment, those who are pregnant or breastfeeding, and individuals with immune system–related diseases will be excluded from the study.

Participants are randomly assigned to three parallel groups receiving HABES herbal syrup, Golnar capsule, or active control (tranexamic acid), according to the study protocol.

The primary outcomes of this study include reduction in menstrual bleeding severity assessed by the Pictorial Blood Loss Assessment Chart (PBAC), reduction in the duration of menstrual bleeding, and improvement in quality of life following the interventions.

In this study, participants are allocated to the intervention groups using permuted block randomization. Blocks of three are generated to include all three study arms (HABES herbal syrup, Golnar capsule, and control group). The allocation sequence is created using a random number table and a standardized clinical trial randomization tool. After enrollment and assignment of a unique study identification number, each participant is allocated to one of the three groups according to the predetermined random sequence. This method is applied to ensure balanced group sizes and to minimize allocation bias.

Due to differences in the appearance and administration routes of the interventions (herbal syrup and capsules), blinding of participants and treating physicians was not feasible. In addition, the researcher responsible for patient follow-up was aware of group allocation. However, the statistician responsible for data analysis was blinded to treatment assignments, and all data were provided in a coded format. Therefore, the study is conducted as a single-blind clinical trial.

Data will be reported only in aggregated form without any individual participant identifiers and will include summary results of the primary and secondary outcomes. Individual participant data (IPD) will not be shared.

Data and related documents will be available only after completion of the study and publication of the final results, and solely in aggregated and de-identified form. Individual participant data (IPD) will not be shared at any time.

Access to the study data and related documents will be restricted to members of the research team and authorized regulatory or ethics authorities upon formal request, in accordance with ethical research principles.

The data and related documents will be used solely for scientific, research, and regulatory purposes related to this study. Data access is permitted only in aggregated and de-identified form and in compliance with ethical principles and confidentiality requirements. Any use beyond the scope of this study will require formal approval from the relevant ethics committee and authorization by the research team.

Requests for access to the study data or related documents should be formally submitted to the principal investigator. All requests will be reviewed and approved in accordance with ethical research principles and authorization from the relevant ethics committee.

Requests for access to study data or related documents must be submitted in written form to the principal investigator. The request will be reviewed by the research team to assess scientific relevance and compliance with confidentiality requirements. If necessary, the request will be referred to the relevant ethics committee for approval. Upon final approval, limited access will be granted exclusively to aggregated and de-identified data.