The comparison of jujube compound herbal medicine containing jujube, coriander, fumaria, lentil and chicory with desloratadine on chronic urticaria

Comparison of the number and severity of itching, quality of life in adults with chronic urticaria before and after taking jujube and desloratadine

The Phase 3 clinical trial will be conducted in a parallel, double-blind, randomized design on 60 patients. All randomization steps will be performed on the website https://ctrandomization.cancer.gov using the Clinical Trial Randomization Tool option.

This study is conducted on people with chronic urticaria in Kashan. After diagnosis and completion of the informed consent form, patients are randomly assigned to two treatment groups in a block design. Urticaria Symptoms Questionnaire (UAS) and Quality of Life (CU-Q2OL) are used at the beginning and end of the study. At the end of the study, if there is no improvement, the subjects will be placed on routine treatment. the patients, the researcher, and the statistical analyst are blinded to the treatment groups. For blinding, the drugs are in the same packaging, label, and size.

Inclusion criteria: Patients with chronic urticaria with physician approval, age 12 to 65 years; Exclusion criteria: Allergy to the drug or any of the ingredients in the herbal medicine Jujube compound, pregnancy, severe angioedema, uncontrolled cardiovascular, respiratory, hematological, renal, hepatic, immune system and connective tissue diseases.

Group 1: Recipients of compound jujube syrup manufactured by Barij Essence Pharmaceutical Company containing jujube, chicory, horsetail, lentils and coriander extracts in an amount of 10 cc twice a day for one month. Group 2: Recipients of desloratadine syrup manufactured by Iran Darou Pharmaceutical Company 10 cc twice a day for one month.

Number of hives, severity of itching, quality of life

Randomization is performed using the permuted block randomization method, so that first all 4 blocks containing two codes A and B are prepared (6 blocks), then random blocks are selected by placement using a random number table. These blocks form a sequence of codes A and B equal to the sample size, and each code is randomly assigned to one of the groups. All randomization steps will be performed on the site https://ctrandomization.cancer.gov and using the Clinical Trial Randomization Tool option. The list of relevant codes will remain in the formulation department of Barij Essence Pharmaceutical Company until the completion of the project. This method will provide both blinding and randomization.

The herbal syrup under study is manufactured in the formulation department of Barij Essans Pharmaceutical Company and is identical to Desloratadine (Neotadine) syrup (manufactured by Adora Teb Iran Company) in terms of appearance, size, and color of the glass and is provided in identical packaging. Then, it is coded based on codes previously prepared using a random number table and block randomization method. And it is provided to the project implementers in a mixed form in a carton.