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IRCT20190807044470N1 IRCT 2019-11-27 Tehran University of Medical Sciences Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis اوستئوآرتریت زانو Knee osteoarthritis (KOA Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis patients with functional dyspepsia compared to the control group: randomized double-blind clinical trial 2019-12-06 anticipated 100 Complete https://irct.ir/trial/42976 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups based on the problem of concurrent dyspepsia as strata after entering the study.Then, randomization is performed for each group using the permuted block randomization method, with patients block size of four. We use https://www.sealedenvelope.com to create a random sequence, Blinding description: The patients, drug deliverers, clinical caregivers, data collectors and outcome assessors are blind in study. 3 Condition 1: Knee osteoarthritis. Condition 2: Functional dyspepsia. Intervention 1: Intervention group 1: patients who receive oral capsule ( 500 mg) of Dawa-Balgham containing Nigella sativa L.,Trachyspermum ammi, zataria multiflora and mastic (gum) after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks. Intervention 2: Control group: the patients who receive placebo containing 125 mili gram toast powder after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks. Yes - There is a plan to make this available What will be shared: Information about the main outcome of this study will be shared through the article. When: The start of the access period will be 6 month after the results are printed. To whom: Researchers working in academia and academics and industry professionals Conditions: For further studies in the treatment of knee osteoarthritis based on our study protocol Where to obtain: Fariba Hadi: hadiyari1000@gmail.com How to obtain: Written request by email one month after publication of the article Comments:
public Fariba Hadi
Faculty of Iranian Medicine, No. 27, North Supervisor Street, West Taleghani Ave.
Tehran Iran (Islamic Republic of) 141663361 009888974535 hadiyari1000@gmail.com Tehran University of Medical Sciences scientific Fatemeh Nejatbakhsh
Faculty of Iranian Medicine, No. 27, North Supervisor Street, West Taleghani Ave.
Tehran Iran (Islamic Republic of) 141663361 +98 21 8897 4535 Nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Knee pain at least one for most days of the prior month, in addition to at least 5 of the following 6: Crepitus on active joint motion Morning stiffness less than 30 minutes’ duration Bony enlargement of the knee on examination Bony tenderness of the knee on examination No palpable warmth. Age older than 50 years Average pain on the Visual Analogue Scale ( VAS ) ≥30 out of 100 mm. 50 years no limit Both History of knee surgery Knee pain related to rheumatological disease or other conditions such as infectious diseases Pregnancy and breast feeding Presence of inflammatory rheumatic diseases Being treated with any of the complementary medicine the prior 3 month Self management of pain by sedatives and anti inflammatory drugs Using of corticostereoid less than last 5 weeks ago Intra-articular depo corticostereoid injection in less than 3 last months. Intra articular hyaloronate injection in less than past 6 months Arthroscopy in past one years history of Significant knee trauma in less than past 6 months Contraindication for paracetamol using history of severe cardiac,renal and liver disease Anticoagulant drugs using Worrying in heat and dryness M17 K30 Osteoarthritis of knee Functional dyspepsia Treatment - Drugs Placebo Intervention group 1: patients who receive oral capsule ( 500 mg) of Dawa-Balgham containing Nigella sativa L.,Trachyspermum ammi, zataria multiflora and mastic (gum) after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks. Control group: the patients who receive placebo containing 125 mili gram toast powder after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks. Pain severity score on the visual analogue scale. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules. Method of measurement: Visual analogue Scale. Functional dyspepsia severity score. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules. Method of measurement: the Leeds Dyspepsia Questionnaire (LDQ). Quality of life score. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Diagnose of functional dyspepsia score. Timepoint: At baseline (before baseline). Method of measurement: Rome III questionnaire. Tehran University of Medical Sciences Approved 2019-10-06 Iran National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)