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IRCT20120506009651N3 IRCT 2022-04-04 Shiraz University of Medical Sciences Effect of Aniseed in treatment of gastrointestinal symptoms in Coronavirus disease Efficacy of Aniseed powder formulation (Aniseed Safoof) to improve gastrointestinal symptoms in COVID-19 patients 2022-03-26 anticipated 225 Complete https://irct.ir/trial/10212 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted randomization method of block randomization. Blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have 4 blocks (including 1 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: The assessor and data analyst will be blind to the random assignment of patients in groups. 3 COVID-19 infection. Intervention 1: Intervention group: Anise edible powder or anise safoof is a combination of anise fruit powder and candy powder. The method of preparation of this drug form is by grinding & sieving techniques and after grinding the components of the formula with the electric mill of Ultra Centrifugal Mill to deliver the drug to the gastrointestinal tract efficiently. This oral powder is formulated in the form of 5 g sachets in the Pharmaceutics Laboratory of Shiraz School of Pharmacy and enters the clinical phase after confirmation of physicochemical and microbial pharmacopoeia tests from the central laboratory of Shiraz University of Medical Sciences. In the clinical phase and at the beginning of the study, patients in the intervention group are instructed to drink the contents of one sachet of anise powder with a glass of water twice a day for two weeks, in addition to the usual treatment protocol. Gastrointestinal symptoms will be recorded at the beginning of the study and before the start of treatment, and during two weeks the response to treatment, including improvement or reduction of gastrointestinal symptoms, diarrhea, anorexia, nausea and abdominal pain compared to the pre-treatment status in each patient is assessed. Intervention 2: Control group: For 2 weeks, no intervention will be performed on patients in the control group except for the usual treatment protocol. Gastrointestinal symptoms are recorded at the beginning of the study and before treatment, and during two weeks, response to treatment, including improvement or reduction of gastrointestinal symptoms, diarrhea, anorexia, nausea, and abdominal pain, is assessed relative to the pre-treatment status in each patient. 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 more information.
public Dr. Mehdi Pasalar
Research Center for Traditional Medicine and History of Medicine, School of Medicine, Zand Avenue
Shiraz Iran (Islamic Republic of) 7134845794 009832084029 pasalar@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Maryam Mosaffa-Jahromi
Research Center for Traditional Medicine and History of Medicine, School of Medicine, Zand Avenue
Shiraz Iran (Islamic Republic of) 7134845794 009832084037 mosaffam@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients from 18 years old to 70 years old with a diagnosis of Coronavirus based on clinical and laboratory symptoms; hospitalization, home quarantine and outpatients Diarrhea, anorexia, nausea or vomiting and abdominal pain within 24-48 hr 18 years 70 years Both Pregnant or nursing females Organic disorders with survival time of less than 3 days Significant allergic reactions to the herbal drug U07.1 Covid-19, confirmed cases, positive test result Treatment - Drugs Other Intervention group: Anise edible powder or anise safoof is a combination of anise fruit powder and candy powder. The method of preparation of this drug form is by grinding & sieving techniques and after grinding the components of the formula with the electric mill of Ultra Centrifugal Mill to deliver the drug to the gastrointestinal tract efficiently. This oral powder is formulated in the form of 5 g sachets in the Pharmaceutics Laboratory of Shiraz School of Pharmacy and enters the clinical phase after confirmation of physicochemical and microbial pharmacopoeia tests from the central laboratory of Shiraz University of Medical Sciences. In the clinical phase and at the beginning of the study, patients in the intervention group are instructed to drink the contents of one sachet of anise powder with a glass of water twice a day for two weeks, in addition to the usual treatment protocol. Gastrointestinal symptoms will be recorded at the beginning of the study and before the start of treatment, and during two weeks the response to treatment, including improvement or reduction of gastrointestinal symptoms, diarrhea, anorexia, nausea and abdominal pain compared to the pre-treatment status in each patient is assessed. Control group: For 2 weeks, no intervention will be performed on patients in the control group except for the usual treatment protocol. Gastrointestinal symptoms are recorded at the beginning of the study and before treatment, and during two weeks, response to treatment, including improvement or reduction of gastrointestinal symptoms, diarrhea, anorexia, nausea, and abdominal pain, is assessed relative to the pre-treatment status in each patient. Diarrhea. Timepoint: Before and after intervention. Method of measurement: Visual analogue scale (VAS) questionnaire which graded from zero (no sign) to 10 (severe sign). Anorexia. Timepoint: Before and after intervention. Method of measurement: Visual analogue scale (VAS) questionnaire which graded from zero (no sign) to 10 (severe sign). Abdominal pain. Timepoint: Before and after intervention. Method of measurement: Visual analogue scale (VAS) questionnaire which graded from zero (no sign) to 10 (severe sign). Gastrointestinal disorders. Timepoint: End of Treatment (2 weeks after starting intervention). Method of measurement: Visual analogue scale (VAS) questionnaire. Shiraz University of Medical Sciences Approved 2022-03-02 Ethics Committee, Shiraz University of Medical Sciences 7th floor, Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)