]>
IRCT20171109037332N2 IRCT 2022-04-19 Kerman University of Medical Sciences Evaluation of the effect of low-dose naltrexone in patients with Trigeminal Neuralgia and Chronic migraine patients Clinical Trial on the efficacy of low dose naltrexone vs placebo on pain intensity in Trigeminal Neuralgia and Chronic migraine patients 2022-05-22 anticipated 40 Complete https://irct.ir/trial/62918 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: Patients will be randomly divided into two groups by placing the numbers 1 to 40 on the balls and placing them in a box and asking the patient to pick up a ball. If the ball removed by the patient was an odd number, the patient will be in the first group, and if the removed ball shows an even number, the patient will be in the second group. Finally, the ball is removed from the box by the patient and is no longer placed inside the box, Blinding description: In this study, patients are blinded to the period they are taking placebo or medication. 3 Condition 1: Trigeminal Neuralgia. Condition 2: Chronic Migraine. Intervention 1: Intervention group 1: First two weeks of placebo and then eight weeks of low-dose naltrexalone (4.5 mg) will be given. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms. Intervention 2: Intervention group 2: first eight weeks of low-dose naltrexalone (4.5 mg) and then two weeks of placebo. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms. Yes - There is a plan to make this available What will be shared: Data files entitled "Evaluation of the effect of low-dose naltrexone and placebo on pain intensity in patients with trigeminal neuralgia and refractory migraine after potentially unidentifiable individuals are shared" When: Start access 6 months after publishing results To whom: The data file can be requested and received by all people, whether working in academia or in industry. Conditions: After requesting and receiving the data file, applicants are allowed to make any use of the documents if asked and allowed by researchers.Individuals can request documentation by email and no conditions are required for their receipt. Where to obtain: Individuals can request data documentation by email to Dr. Goli Chamani (golichamani@yahoo.com). How to obtain: Individuals can email Dr. Goli Chamani (the first person in the article) 6 months after the publication of the results to access the data and documents, and about 1 month later the documents and data will be sent to them. Comments:
public Homa Kamyabi
Shafa St., School of Dentistry
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9028 h.kamyabi1244@gmail.com Kerman University of Medical Sciences scientific Goli Chamani
Shafa St., Faculty of Dentistry
kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9028 h.kamyabi1244@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) According to ICHD3 criteria, they are diagnosed with TN or chronic headache. Be over 18 years old Have the necessary cooperation to participate in the study. 18 years no limit Both Patient non-cooperation The patient is pregnant or breastfeeding. If the patient uses opioid analgesics or inhales opioids If the patient regularly uses anti-inflammatory drugs. Known allergy or reaction to naltrexone If the patient consumes alcohol and can not refrain from consuming it during the study. The patient has rheumatic or autoimmune diseases The patient has been diagnosed with a mental illness that disrupts his or her collaboration in the study. G50.0 G43.7 Trigeminal neuralgia Chronic migraine without aura Other Other Intervention group 1: First two weeks of placebo and then eight weeks of low-dose naltrexalone (4.5 mg) will be given. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms. Intervention group 2: first eight weeks of low-dose naltrexalone (4.5 mg) and then two weeks of placebo. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms. Low-dose naltrexone, chronic migraine, trigeminal neuralgia. Timepoint: Before the intervention and every day during the intervention. Method of measurement: VAS questionnaire. Kerman University of Medical Sciences Approved 2022-04-18 Ethics committee of Kerman University of Medical Sciences Kerman school of dentistry, Shafa Ave. Kerman Kerman Iran (Islamic Republic of)