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IRCT20201111049349N1 IRCT 2021-11-10 Shahed University Effect of dry cupping therapy and galbanum oil in treatment of coronavirus patients Evaluating the effect of topical combination galbanum oil and dry cupping therapy to alleviate COVID-19 patients symptoms 2021-11-22 anticipated 60 Complete https://irct.ir/trial/52471 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving cupping and control group (Assignment). Then based on blocks and allocation sequences cupping therapy will be given to patients. This is an open-label study and blinding will not happen. 3 Coronavirus infection. Intervention 1: Intervention group: The group which receive cupping therapy with galbanum oil application and standard medicines. Preparation of medicine:To prepare galbanum essential oil, galbanum gum is prepared from a suitable type of reputable herbal market and then, after the approval of a botanist, the voucher number is received from the herbarium of Faculty of Pharmacy, University of Tehran. Then, to prepare its essential oil, 200 g galbanum is poured into a balloon. Then, using water distillation method (hydrodistillation) and Clevenger apparatus, essential oil is extracted for 4 hours and the oil percentage is calculated (V/W). The water residue is removed by anhydrous sodium sulfate and the achieved oil is stored in a dark container in a refrigerator at 4-5°C prior to use in formulation or in hexane or petroleum ether solvent for essential oil components analysis by GC /MS.The achieved galbanum essential oil was then mixed with Almond violet oil (10%) ( Tuba Green Gold Company) with the ratio of 5:95 and stir to make homogeneous formulation. Intervention 2: Control group: The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: After publishing the article To whom: The results will be available to researchers working in academic and scientific institutions Conditions: After the publication of the article for further and supplementary studies and clinical and therapeutic applications Where to obtain: Responsible for public accountability How to obtain: Communicate with the public accountant Comments:
public Fateme Seydi
1nd floor, No 43, East Shahid Hajisadghi Avenue,Dardasht Avenue ,Narma
Tehran Iran (Islamic Republic of) 1651813911 +98 21 7793 8493 fateme.seydi1444@gmail.com Shahed University scientific Maryam Iranzad Asl
Tehran-Qom Highway Opposite side of Imam Khomeini Holy Shrine Tehran, Shahed University, Department of traditional medicine
Tehran Iran (Islamic Republic of) 33191​18651 +98 21 5121 4055 m_iranzadasl@yahoo.com Shahed University Iran (Islamic Republic of) Positive PCR ‎test From 18 to 80 years old (male and female) Clinical criteria for hospitalization (fever ≥ 38 °C- sever cough or shortness of breath or blood oxygen saturation≤ 93% or respiratory Rate ≥24 breaths/minute or positive CPR Completion of the informed consent form by the patient or his/her companions 18 years 80 years Both Pregnancy or breastfeeding intubation Existence of any history of allergies and skin allergies to the consumption of any of the components of the herbal product Hearth failure renal failure Receive chemotherapy vertebral fracture or herniated disc Open wound at the site of cupping Inability and unwillingness of the patient to fill out a personal consent form to enter the study Coagulation disease Immune Deficiency Disease B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Devices Intervention group: The group which receive cupping therapy with galbanum oil application and standard medicines. Preparation of medicine:To prepare galbanum essential oil, galbanum gum is prepared from a suitable type of reputable herbal market and then, after the approval of a botanist, the voucher number is received from the herbarium of Faculty of Pharmacy, University of Tehran. Then, to prepare its essential oil, 200 g galbanum is poured into a balloon. Then, using water distillation method (hydrodistillation) and Clevenger apparatus, essential oil is extracted for 4 hours and the oil percentage is calculated (V/W). The water residue is removed by anhydrous sodium sulfate and the achieved oil is stored in a dark container in a refrigerator at 4-5°C prior to use in formulation or in hexane or petroleum ether solvent for essential oil components analysis by GC /MS.The achieved galbanum essential oil was then mixed with Almond violet oil (10%) ( Tuba Green Gold Company) with the ratio of 5:95 and stir to make homogeneous formulation. Control group: The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health. Percentage of blood oxygen saturation. Timepoint: Before the intervention and days 1,2,3,4,5 after the intervention. Method of measurement: Pulse oximeter device. Sevierty of cough. Timepoint: Before the intervention and days 1,2,3,4,5 after the intervention. Method of measurement: CTCAE version 5 (Common Terminology Criteriafor Adverse Events Version 5.0). Severe need for oxygen therapy. Timepoint: Before the intervention and days 1,2,3,4,5 after the intervention. Method of measurement: CTCAE version 5. Sevierty of dyspnea. Timepoint: Before the intervention and days 1,2,3,4,5 after the intervention. Method of measurement: CTCAE version 5. Sevierty of Chest pain (non-cardiac). Timepoint: Before the intervention and days 1,2,3,4,5 after the intervention. Method of measurement: CTCAE version 5. Shahed University Approved 2020-10-27 Ethics Committee of Shahed University Tehran-Qom Highway, Opposite side of Imam Khomeini Holy Shrine, Tehran Tehran Tehran Iran (Islamic Republic of)