]>
IRCT20220117053748N1 IRCT 2022-02-01 Islamic Azad University The Effect of Capsaicin on Burning Moth VAS The Effect of Capsaicin Oral Solution in The Treatment of Burning Mouth in Patients Attending School of Dentistry and Affiliated Hospitals of Tehran Islamic Azad University of Medical Sciences 2022-02-09 anticipated 22 Complete https://irct.ir/trial/61360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of participants in the study by the group statistician to random 4 blocks will be done using the Rand option of Excel software. Then, according to the number of samples, envelopes will be prepared in the package and given to the random person. Prior to treatment, the oral solution of capsaicin and placebo will be coded by someone outside the clinical research team. Therefore, both the patient and the evaluator will be blind, Blinding description: Prior to treatment, the oral solution of capsaicin and placebo will be coded by someone outside the clinical research team. Therefore, both the participants in the study and the outcome evaluator will be blind. 2-3 Condition 1: Burning mouth. Condition 2: Dry mouth. Intervention 1: Intervention group: Capsaicin oral solution using 10% extract of a mixture of coriander (Coriandrum sativum L.) and Hypericum perforatum (Hypericum perforatum L.) which was prepared by accelerated solvent method and 0.25% of Capsaicin in hydroalcoholic base with مiquid fructose solution and polyethylene glycol are formulated and standardized based on the presence of Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day for 30 days and gargle for at least 2 minutes. Intervention 2: Control group: This oral solution has been formulated using permitted pharmaceutical food dyes based on hydroalcoholic as well as liquid fructose solution and PEG, but without the use of coriander fruit extract, Hypericum perforatum and Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day and gargle for at least 2 minutes. 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 Kimia Ghods
No. 9, 9th Neystan Street, Pasdaran Street
Tehran Iran (Islamic Republic of) 1931843511 +98 21 2269 2735 kimiaghods2@gmail.com Islamic Azad University scientific Kimia Ghods
No. 9, 9th Neystan Street, Pasdaran Street
Tehran Iran (Islamic Republic of) 1931843511 +98 21 2269 2735 kimiaghods2@gmail.com Islamic Azad University Iran (Islamic Republic of) Absence of systemic disease Existence of daily sensation of bilateral burning mouth continuously (4 to 6 months) and without obvious clinical symptoms Improve the symptoms of burning mouth by eating food or drinking water Non-interference of burning mouth with the patient's sleep 30 years 80 years Both Existence of any throat and nose lesions clinically Existence of any local factor or systemic disease Herbal or chemical drugs consumption Existence of hypersensitivity reactions Existence of physical or chemical agents Existence of complete dentures, bad oral habits such asBruxism, oral mucosal diseases such as lichen planus, benign migratory glossitis, and bacterial, fungal, and viral infections.Neurological problems, endocrine disorders, anemia, gastrointestinal diseases, malnutrition, pregnancy and lactation, and pepper allergy Existence of bad oral habits like Bruxism Existence of oral mucosal diseases such as Lichen planus, benign migratory glossitis, and bacterial, fungal, and viral infections Existence of neurological problems Existence of endocrine disorders Existence of anemia Existence of gastrointestinal diseases Existence of malnutrition Pregnancy and lactation Existence of pepper allergy T28.0 R68.2 Burn of mouth and pharynx Dry mouth, unspecified Treatment - Drugs Placebo Intervention group: Capsaicin oral solution using 10% extract of a mixture of coriander (Coriandrum sativum L.) and Hypericum perforatum (Hypericum perforatum L.) which was prepared by accelerated solvent method and 0.25% of Capsaicin in hydroalcoholic base with مiquid fructose solution and polyethylene glycol are formulated and standardized based on the presence of Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day for 30 days and gargle for at least 2 minutes. Control group: This oral solution has been formulated using permitted pharmaceutical food dyes based on hydroalcoholic as well as liquid fructose solution and PEG, but without the use of coriander fruit extract, Hypericum perforatum and Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day and gargle for at least 2 minutes. Burning score in the standard burning mouth questionnaire. Timepoint: Filling in the mouth burning questionnaire at the beginning of the study (before the intervention) and on days 0 and 30 after starting the capsaicin solution. Method of measurement: Standard burning mouth questionnaire. Amount of Xerostomia. Timepoint: At the beginning of the study (before the intervention) and day 0, 30 after the start of capsaicin solution. Method of measurement: Standard dry mouth questionnaire. Islamic Azad University Approved 2022-01-10 Research Ethics Committees of Islamic Azad University - Dental Branch Tehran - Iran No. 9, 9th Neystan Street, Pasdaran Street Tehran Tehran Iran (Islamic Republic of)