]>
IRCT20251221068398N1 IRCT 2026-02-11 Bouali Darou Pharmaceutical Company, Qom, Iran Therapeutic effects of herbal medicines on abnormal uterine bleeding Investigating the therapeutic effects of HABES herbal syrup on abnormal uterine bleeding in women with hypermenorrhea 2026-02-09 anticipated 66 Recruiting https://irct.ir/trial/88407 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 Abnormal Uterine Bleeding (Hypermenorrhea / Menorrhagia). Intervention 1: Intervention group: Grupo de intervención uno: Las pacientes de este grupo reciben cápsulas de Golnar, que contienen Punica granatum y Astragalus gossypinus. La dosis es de tres porciones al día (4 cápsulas por porción; 2 antes y 2 después de las comidas), del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. Intervention 2: Intervention group: Grupo de intervención dos: Las pacientes de este grupo reciben jarabe de hierbas Habes, que contiene extractos de cola de caballo, lenteja, zumaque y Golnar. La dosis es de dos cucharadas cada 4 horas, del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. Intervention 3: Control group: Grupo de control: Las pacientes de este grupo reciben cápsulas de ácido tranexámico. La dosis diaria es de 2 cápsulas por vía oral, del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the clinical nature of the study and the sensitivity of participants’ personal and medical information, no decision has been made to share individual participant data (IPD). All data will be kept confidential and reported only in aggregated form without any possibility of participant identification. Access to raw data will be restricted to the research team and will be granted solely in accordance with ethical research principles.
public Hoda Fazaeli
Royā Infertility Treatment Center, Academic Center for Education, Culture and Research (ACECR), Shahid Karimi Blvd., Shabnam St., Qom, Iran
Qom Iran (Islamic Republic of) 3713189934 +98 25 3270 0155 hodafazaely@yahoo.com Iranian academic center for education culture and research scientific Hoda Fazaeli
Royā Infertility Treatment Center, Academic Center for Education, Culture and Research (ACECR), Shahid Karimi Blvd., Shabnam St., Qom, Iran
Qom Iran (Islamic Republic of) 3713189934 +98 25 3270 0155 hodafazaely@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Women diagnosed with menorrhagia (hypermenorrhea) due to uterine fibroid or endometrial polyp who are candidates for hysteroscopy Age between 20 and 55 years Menstrual bleeding lasting more than 7 days with abnormal uterine bleeding at irregular intervals 20 years 55 years Female Presence of gastrointestinal disorders or any chronic disease requiring long-term treatment Pregnancy or breastfeeding History of immune system–related diseases Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Grupo de intervención uno: Las pacientes de este grupo reciben cápsulas de Golnar, que contienen Punica granatum y Astragalus gossypinus. La dosis es de tres porciones al día (4 cápsulas por porción; 2 antes y 2 después de las comidas), del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. Intervention group: Grupo de intervención dos: Las pacientes de este grupo reciben jarabe de hierbas Habes, que contiene extractos de cola de caballo, lenteja, zumaque y Golnar. La dosis es de dos cucharadas cada 4 horas, del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. Control group: Grupo de control: Las pacientes de este grupo reciben cápsulas de ácido tranexámico. La dosis diaria es de 2 cápsulas por vía oral, del cuarto al séptimo día de menstruación, durante dos ciclos menstruales consecutivos. The primary outcome measures 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. Timepoint: Outcome variables are measured at three time points: at baseline before the intervention, at the end of the second menstrual cycle following the intervention, and 60 days after completion of the intervention as a follow-up assessment. Method of measurement: Bleeding severity is assessed using the Pictorial Blood Loss Assessment Chart (PBAC), bleeding duration is recorded as the number of menstrual days, quality of life is evaluated using a standardized questionnaire, and laboratory variables are measured by blood tests (CBC, PT, INR, fibrinogen, and serum creatinine). The secondary outcome variables include changes in hematological parameters related to anemia (CBC including hemoglobin, hematocrit, red blood cell count, and platelet count), coagulation parameters (PT, INR, and fibrinogen) to assess hemostatic effects and safety, and changes in serum creatinine levels to evaluate potential treatment-related toxicity. Timepoint: Measurements of variables are performed at three time points: before the start of the intervention (baseline), at the end of the second menstrual cycle after receiving the intervention, and 60 days after the end of the intervention as a follow-up period. Method of measurement: Bleeding severity is assessed using the Pictorial Blood Loss Assessment Chart (PBAC), bleeding duration is measured by recording the number of menstrual days, quality of life is evaluated using a standardized questionnaire, and laboratory parameters are assessed through blood tests including CBC, PT, INR, fibrinogen, and serum creatinine. Bouali Darou Pharmaceutical Company, Qom, Iran Approved 2025-12-24 Academic Center for Education, Culture and Research (ACECR), Mashhad, Iran Royā Infertility Treatment Center, Academic Center for Education, Culture and Research (ACECR), Shahid Karimi Blvd., Shabnam St., Qom, Iran qom Ghoum Iran (Islamic Republic of)