Comparing the effect of herbal soft gel containing dry extract of willow bark, Shirazi chamomile, red pepper, ginger root, cranberry, garlic powder, and hawthorn with placebo on cardiovascular disease risk factors in patients with hyperlipidemia

Determining the effect of herbal soft gel containing dry extract of willow bark, Shirazi chamomile, red pepper, ginger root, cranberry, garlic powder, and hawthorn on cardiovascular disease risk factors in patients with hyperlipidemia

A controlled clinical trial, conducted in parallel, triple-blind, phase 3, randomized in a block design using a sealed envelope site on 70 patients.

This study is a randomized, triple-blind (patient, researcher, laboratory expert, and statistical analyst), parallel-group clinical trial. Seventy patients with primary hyperlipidemia aged 18 to 60 years (2 groups of 35 for the intervention and placebo groups) from Isfahan city, respectively, from those referring to the Chamran Heart Hospital clinic who meet the inclusion criteria, are invited to participate in this زlinical trial.

Inclusion criteria: Age 18 to 60 years; Individuals with primary hyperlipidemia and low risk of heart disease; Body mass index below 30 kg/m2. Exclusion criteria: Use of alcohol and/or other substances of abuse; Use of medications or supplements affecting serum lipids in the past 2 months; Pregnancy and lactation (women)

Intervention group: The drug group take one softgel for 90 days with lunch including some herbal containing hydroalcoholic extract of garlic 47.4 mg, cranberry 20.4 mg, ginger 14.8 mg, red pepper 9.3 mg, hawthorn 44.4 mg, chamomile 4.8 mg, and willow 14.8 mg. Control group: Placebo group take one same tablet for 90 days with lunch

Blood lipids include serum levels of total cholesterol (TC); triglycerides (TG); low-density lipoprotein cholesterol (LDL-C); high-density lipoprotein cholesterol (HDL-C)

1. Study Design: This trial uses a “Stratified Blocked Randomization” method to maintain balance between intervention and control groups on key variables that may influence outcomes (age and body mass index). 2. Stratification: Participants are divided into four strata based on two variables: 1. Age: 20 to 40 years / 41 to 60 years 2. BMI: 20 to 27.5 kg/m² / 27.5 to 30 kg/m² • Each participant is placed in one of four strata based on a combination of age and BMI. 3.Blocking: • In each stratum, randomization is performed using balanced blocks. • Block size: Blocks are determined as a variable of 4 to prevent researchers from predicting the sequence of allocation. That is, two participants are assigned to the intervention group and two to the control group. The order of allocation in each block is determined randomly (for example, AABB, ABAB, BAAB). 4. Random sequence generation: Random sequences are generated separately for each stratum by the Sealed Envelope site. 5. . Sequence Concealment: • The randomization process is performed by an independent researcher (not involved in the data collection or intervention phases). • The allocation sequence is kept secret until the participant registers in the system and uses a “digital sealed envelope” mechanism. • After recording baseline information (age and BMI), the independent researcher opens the block corresponding to the participant stratum in the system and announces the intervention or control group. This process prevents selection bias.

During the study, the patient, the prescriber, and the statistical analyst were unaware of the group assignment. The drug and placebo were identical in color, shape, size, and odor, and were coded A and B by an independent randomizer.

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