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IRCT20250405065212N1 IRCT 2025-04-19 Mashhad University of Medical Sciences Investigating the effect of Valeriana officinalis extract on echocardiographic, laboratory and clinical parameters in patients with heart failure with reduced ejection fraction Investigating the effect of Valeriana officinalis extract on echocardiographic, laboratory and clinical parameters in patients with heart failure with reduced ejection fraction 2025-04-21 anticipated 68 Complete https://irct.ir/trial/82833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Methodology for Random Sequence Generation with Software or Website Specification: Randomization was achieved using a random number table generated from the website www.randomization.com. In this study, a block randomization method was employed to generate a sequence of random numbers. This method utilized 20 blocks of size 4 and 20 blocks of size 2, randomly selected from combinations of letters A and B using the random number table. The list of blocks of size 2 includes: 1: AB and 2: BA. The list of blocks of size 4 includes: 1: AABB, 2: ABBA, 3: BBAA, 4: BAAB, 5: BABA, 6: ABAB. To select the blocks of size 2, 20 numbers were randomly chosen from the random number table. If the selected number ranged from 0 to 4, the first block was chosen; if the number ranged from 5 to 9, the second block was selected. For selecting the blocks of size 4, 20 numbers were randomly selected from the range of 1 to 6 using the random number table. If the selected number was one, the first block of size four was chosen; if the selected number was two, the second block was chosen, and this procedure continued for the remaining blocks. Allocation Concealment Methodology: The generated allocation sequence was placed in sealed envelopes and will be opened at the time of patient enrollment in the study, Blinding description: Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 3 Left ventricular failure. Intervention 1: Intervention group: Using tablet containing 400 mg of Valeriana officinalis hydroalcoholic extract administered once daily + standard heart failure therapy. Intervention 2: Control group: Taking placebo tablets four times a day along with standard treatments. 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 No additional data
public Parnian Salehi
Ahmadabad Blvd
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0001 salehip4011@mums.ac.ir Mashhad University of Medical Sciences scientific Parnian Salehi
Ahmadabad Blvd
Mashhad Iran (Islamic Republic of) 99199-91766 +98 23 3223 9591 salehip4011@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age ≥ 18 years Diagnosis of heart failure with systolic dysfunction Provision of informed consent for study participation 18 years no limit Both Class IV heart failure according to the New York Heart Association (NYHA) criteria History of renal dysfunction (GFR < 20 mL/min/1.73m²) History of hepatic dysfunction (LFT > 3 × ULN) Severe underweight (BMI ≤ 18.5 kg/m²) Use of warfarin, lithium, or chemotherapeutic agents Pregnancy or suspected pregnancy Other underlying conditions or comorbidities, including active infections, major surgeries, type 1 diabetes, pituitary or adrenal insufficiency, malnutrition, substance abuse or dependence, gastrointestinal disorders, or malignancy. Occurrence of a serious adverse event during the study (e.g., hypersensitivity reaction) Patient withdrawal of consent Unwillingness to continue participation I50.1 - Le Left ventricular failure Treatment - Drugs Placebo Intervention group: Using tablet containing 400 mg of Valeriana officinalis hydroalcoholic extract administered once daily + standard heart failure therapy Control group: Taking placebo tablets four times a day along with standard treatments Echocardiographic parameters (LVEF, RV strain, PAP, RV diameter). Timepoint: Before intervention and 3 month after intervention. Method of measurement: Echocardiography. Laboratory parameters (CBC, CRP, Chol, TG, LDH, ALT, AST, uric acid). Timepoint: Before intervention and 3 month after intervention. Method of measurement: measured from fasting venous blood using standardized automated analyzers. CHFQOLQ-20(Congestive Heart Failure Quality of Life Questionnaire (20-item version)) questionnaire. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Completion of questionnaires. Mashhad University of Medical Sciences Approved 2025-01-20 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences School of Medicine, University pardis, Eastern Entrance at Azadi Square, Kalantari Highway, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)