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

Phase 3 randomized Double-blinded placebo parallel clinical trial on 68 patients. Randomization using Randomaization.com

This randomized clinical trial at Ghaem Hospital (Mashhad) will enroll patients randomly assigned to receive either active drug or identical placebo (double-blinded design with unique patient codes). Evaluations occur at baseline and 3-month follow-up.

Inclusion Criteria: Age ≥18 years, Heart failure with systolic dysfunction, Informed consent. And Exclusion Criteria: NYHA Class IV heart failure, Renal impairment (GFR <20 mL/min/1.73m²), Liver dysfunction (LFT >3×ULN), Low BMI (≤18.5 kg/m²), Use of: warfarin/lithium/chemotherapy, Pregnancy, Major comorbidities, Serious adverse reactions, Drug intolerance, Withdrawal of consent

Intervention group: Taking Hydroalcoholic extract of Valeriana officinalis L tablets daily along with standard treatments. Placebo group: Taking placebo tablets daily along with standard treatments

Echocardiographic parameters (LVEF, RV strain, PAP, RV diameter), laboratory parameters (CBC, CRP, Chol, TG, LDH, ALT, AST, uric acid), and the CHFQOLQ-20 questionnaire.

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 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