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IRCT20230712058750N1 IRCT 2023-12-29 Mashhad University of Medical Sciences The effect of herbal topical cream in reducing pain caused by neuropathy and joint pain Investigating the therapeutic effect of herbal supplement (Herbal topical cream containing lavender, mint, cinnamon, ginger, moringa, poppy extract and clove extract.) in order to reduce chemotherapy-induced neuropathy, muscle pain and response to treatment 2023-11-22 anticipated 60 Complete https://irct.ir/trial/71323 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This randomized study will be of the block type, the type of double-blind blinding, and the method of concealing the allocation of the study will be sealed opaque envelopes, which is the SNOSE method (sequentially numbered, opaque, sealed envelopes) by one of the team members and Random numbers will be prepared and printed and will be placed inside the envelope. The door of the envelope will be closed and its contents cannot be seen from the outside. Then, first, the purpose of the study will be explained to the person who meets the specified conditions, and if the person wishes, the form will be filled. Sign the informed consent and take an envelope and then open it and enter the person in the intervention or control group based on the contents of the envelope, Blinding description: This is a double-blind experiment that will be blind for the people participating in the study. Herbal pain reliever cream and placebo cream were prepared based on Vaseline and ostrich oil (it is the same in terms of color and shape, in order to make the aroma and smell of the placebo cream similar to the herbal cream, inside the containers before filling with the placebo cream, with a solution containing The plants and extracts used were washed). 3 People with neuropathy or joint and muscle pain. Intervention 1: Intervention group: patients with neuropathic pain and joint pain, 50 grams of topical herbal cream, one gram of lavender, three grams of clove extract, one and a half grams of mint, two grams of cinnamon, half a gram of ginger, two tenths of grams of moringa, one cc of poppy extract of this cream. Cream based on vaseline and ostrich oil (made in Mashhad Medical Sciences Faculty) was used topically daily for 4 weeks during pain. Intervention 2: Control group: patients with neuropathic pain and joint pain used placebo cream (made in Mashhad Medical Sciences Faculty) topically daily during pain for 4 weeks. Yes - There is a plan to make this available What will be shared: We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study. When: starting in January 2025 To whom: Sharing of all collected de-identified participants data (IPD) will be started immediately after publication. people working in academic institutions or people working in businesses Conditions: The collected de-identified participants data (IPD) will be only shared to those recipients who commit themselves to use them only for patients. They also should commit themselves to share these data with other organization only after asking permission from the original source. Where to obtain: Data/Documents will be obtainable by sending an e-mail to avana@mums.ac.ir How to obtain: Data/Documents will be obtainable by sending an e-mail to avana@mums.ac.ir Comments:
public AMIR AVAN
Medical genetics, faculty of medicine
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2298 amir_avan@yahoo.com Mashhad University of Medical Sciences scientific AMIR AVAN
23univercity Ave,taheri5 Blvd
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3841 6015 amir_avan@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients have symptoms of chronic muscle and joint pain. Patients with neuropathic pain caused by chemotherapy 19 years 60 years Both Pregnant or lactating woman Patients who have abdominal abscess at the time of visit. Patients with bacterial infection. Patients who use opioids on a daily basis. Possible side effects of treatment G62.0 Drug-induced polyneuropathy Treatment - Drugs Placebo Intervention group: patients with neuropathic pain and joint pain, 50 grams of topical herbal cream, one gram of lavender, three grams of clove extract, one and a half grams of mint, two grams of cinnamon, half a gram of ginger, two tenths of grams of moringa, one cc of poppy extract of this cream. Cream based on vaseline and ostrich oil (made in Mashhad Medical Sciences Faculty) was used topically daily for 4 weeks during pain. Control group: patients with neuropathic pain and joint pain used placebo cream (made in Mashhad Medical Sciences Faculty) topically daily during pain for 4 weeks. Pain and tingling. Timepoint: before intervention and 10 min, 1 hours , 6 hours after intervention. Method of measurement: Neuropathic Pain Scale (NPS) and Guidelines for the Pharmacological Treatment of Peripheral Neuropathic Pain: Expert Panel Recommendations for the Middle East Region. Mashhad University of Medical Sciences Approved 2023-06-27 Ethics committee of Medical School of Mashhad University of Medical Sciences vakil abad sq., faculty of medicine mashhad Razavi Khorasan Iran (Islamic Republic of)