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IRCT20131218015860N6 IRCT 2021-07-06 Shahid Beheshti University of Medical Sciences Evaluation of the efficacy of Trachyspermum ammi topical cream on neuropathy symptoms in cancer patients Evaluation of the efficacy of Trachyspermum ammi topical cream on taxane induced peripheral neuropathy symptoms in cancer patients : a pilot study 2021-08-23 anticipated 40 Complete https://irct.ir/trial/57086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Restricted Randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. The randomization method will be balanced using block randomization and will be done in 4 blocks using a computer. Each drug is named with a number from 1 to 40. Patients are divided into two groups for the trial: the first and group (20 people) groups or drug groups and the second control group (20 people) placebo group. Both groups are equally divided in terms of characteristics and conditions. The control group is assigned to "A" and the intervention group to "B," and then these two groups are divided into 6 blocks of 4: (1)AABB, (2) BBAA, (3) ABAB, (4) B A B A, (5) A B B A, (6) BAAB. These blocks are randomly stacked together by a computer to form a chain of random groups (e.g., BBAA AABB ABAB BABA ABBA BAAB). Patients then enter these groups in the order of enrollment. For randomization, a randomization software for random sequence software called Random allocation software is used. In addition to simple randomization, this software can generate random sequences by block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants. The assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are in the envelopes respectively. Are placed. To maintain a random sequence, the envelopes are numbered in the same way on the outer surface. 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 into the study, one of the envelopes of the letter is opened in order, and the assigned group of the participant is revealed, Blinding description: Trachyspermum ammi topical cream and placebo was coded, patient and researcher were blind. 3 Neoplastic (malignant) related neuropathy. Intervention 1: Intervention group: Trachyspermum Ammi and almond oil in a cream formulation at a rate of 5% of the total cream will be used. Trachyspermum Ammi essential oil (10% of the total cream) will be added to the cream. The cream was filled in white sealed multilayer tubes. Before the clinical trial, cream samples were evaluated pharmacologically (viscosity test, pH assessment, and microbial limit test). The content of thymol, Trachyspermum Ammi cream was standard (02/0 ± 34/2 g per 50 g of cream). . Both creams are white. Cancer patients with taxane-induced neuropathy receive 1 mg of Trachyspermum Ammi topical cream twice a day for four weeks. Intervention 2: Control group: In the placebo formulation, almond oil will be used at the rate of 5% of the total cream (equal to the amount of Trachyspermum Ammi cream) and paraffin oil (10% of the whole cream). The cream was filled in white sealed multi-layered tubes. To create the aroma of placebo cream with Trachyspermum Ammi cream, the inside of the tubes was washed with Trachyspermum Ammi distilled water, before being filled with placebo cream; both creams are white. Cancer patients with taxane-induced peripheral neuropathy, receiving ointment of placebo, 1 mg twice a day for four weeks. 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 There is no more information
public Ghazaleh Heydarirad M.D
No.8 Shams Alley, Opposite Sttree Tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 218877352 dr.ghazalrad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ghazaleh Heydarirad
No.8 Shams Alley, opposite St tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 dr.ghazalrad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with cancer Patients whose neuropathy is due to chemotherapy with taxane drugs or a history of chemotherapy taxane that is a maximum of two months from completion of chemotherapy last Having symptoms of peripheral neuropathy Neuropathy is based on the diagnosis of a neurologist due to chemotherapy Aged between 18 and 80 years Willingness to collaborate in the study 18 years 80 years Both diabetes Carpal tunnel syndrome Reluctance to stay in study Acute psychological symptoms such as depression (taking medication for it) Unforeseen treatments such as surgery, radiation therapy or immunotherapy that were not previously part of the participant's treatment plan Vitamin B6 deficiency or high (diagnosed by doctor and interview) Any signs of allergy or side effects from the drug Deterioration of the patient renal failure Brain metastasis Previous history of axilla or lumbar or pelvic radiotherapy A history of neuropathy due to other conditions that the person had before starting chemotherapy or getting cancer G62.0 Drug-induced polyneuropathy Treatment - Drugs Placebo Intervention group: Trachyspermum Ammi and almond oil in a cream formulation at a rate of 5% of the total cream will be used. Trachyspermum Ammi essential oil (10% of the total cream) will be added to the cream. The cream was filled in white sealed multilayer tubes. Before the clinical trial, cream samples were evaluated pharmacologically (viscosity test, pH assessment, and microbial limit test). The content of thymol, Trachyspermum Ammi cream was standard (02/0 ± 34/2 g per 50 g of cream). . Both creams are white. Cancer patients with taxane-induced neuropathy receive 1 mg of Trachyspermum Ammi topical cream twice a day for four weeks. Control group: In the placebo formulation, almond oil will be used at the rate of 5% of the total cream (equal to the amount of Trachyspermum Ammi cream) and paraffin oil (10% of the whole cream). The cream was filled in white sealed multi-layered tubes. To create the aroma of placebo cream with Trachyspermum Ammi cream, the inside of the tubes was washed with Trachyspermum Ammi distilled water, before being filled with placebo cream; both creams are white. Cancer patients with taxane-induced peripheral neuropathy, receiving ointment of placebo, 1 mg twice a day for four weeks. Pain. Timepoint: Weeks zero and four. Method of measurement: Visual Analogue Scale. Tingling. Timepoint: Weeks zero and four. Method of measurement: Visual Analogue Scale. Symptoms of peripheral neuropathy. Timepoint: Weeks zero and four. Method of measurement: Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-03-09 Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences Shahid Beheshti University of Medical sciences, Daneshju Blv. Tehran Tehran Iran (Islamic Republic of)