Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure : A double blind, randomized controlled trial

Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure

A concealed, randomized, parallel group trial with blinded outcome assessment of 26 patients.

Aloe Vera gel or placebo is given one capsule in the same condition every 12 hours for 8 weeks to the systolic heart failure patients referred to the Yazd Cardiovascular Research Center. The participants will be allocated into two groups of intervention (Aloe Vera) and control (placebo) with titles A and B by using block randomization method. Participants, researcher, person who gives drug and investigators will be blinded to all study. Only the randomization statistician will be unblinded to the treatment assignment.

Inclusion criteria: Written informed consent, age:18 years or above, systolic heart failure with ejection fraction equal or lesser than 40 percent or Heart failure with NYHA Class II-III, continuing heart medications, prescribed by cardiologist, Heart failure stable according to the diagnosis and under the supervision of a heart specialist. Exclusion criteria: Pregnancy, Breast feeding, malignancy, Allergy to Aloe Vera gel, chronic inflammatory disease, severe liver disease, Acute infectious disease, Decompensation heart, History of peptic ulcer and hemorrhoid.

Participants will be given interventions two times a day for next 8 weeks. Each capsule contains 150 mg of Aloe Vera gel or 150 mg starch in the same shape, color and cans.

Minnesota Living with Heart Failure Questionnaire Score (MLHFQ) The distance covered during a Six-Minute Walk Test (6 MWT) Insomnia Severity Index questionnaires score (ISI) Pittsburgh Sleep Quality Index questionnaires score (PSQI) STOP-BANG sleep apnea questionnaires score

There were two modifications to the inclusion criteria: Age: 18 years or above Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.

The block randomization method is used Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks. Since the sample size in this study is 26 cases (13 cases in each group), by using Excel software, 7 blocks of 4 are randomly used. The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment,drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual.

After evaluation by the researcher, participants are referred to the off-site individual(drug Delivery Person) and receive A or B intervention according to a random sequence list The drug and placebo are coded in similar capsules and in identical packages, with the same color and participants, researchers, drug Delivery Person and investigators are not aware of treatment allocation. Only the statistician will be unblinded to the treatment assignment.