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IRCT20080901001157N24 IRCT 2026-05-09 Iranian academic center for education culture and research Effects of Curcuma longa, Piper nigrum and Camellia sinensis mixture on the symptoms of knee osteoarthritis Study on the effects of Curcuma longa, Piper nigrum and Camellia sinensis extract mixture on the symptoms of knee osteoarthritis: a randomized controlled trial 2026-05-21 anticipated 60 Recruiting https://irct.ir/trial/89567 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the block randomization method will be used. By visiting the website www.sealedenvelope.com and selecting the 'Randomization' tab, the 'Make a list' option will be clicked. After specifying the number of intervention groups, the sample size, and the block size (which is set to 4 in this study), a randomized list containing specific patient codes will be generated and used for the randomization process. A randomly generated list will be used to create a series of sequentially numbered, sealed envelopes. Each envelope will be marked with a unique patient code, and inside will be a card indicating the assigned intervention group. Following the enrollment of each eligible patient, the envelope corresponding to the next sequential code will be opened by the researcher. The patient will then be assigned to their intervention group based on the card contained within the envelope, Blinding description: Letters A or B are labeled on herbal medicine or placebo cans. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome, are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo groups, but they are not aware of the type of group they are in. 2-3 Osteoarthritis. Intervention 1: Intervention group: Patients will orally take one 500 mg capsule of the herbal mixture (Curcuma longa, Piper nigrum and Camellia sinensis) produced by the Medicinal Plants Research Center of Jihad Daneshghani, every 12 hours after meals for a period of 2 months. Intervention 2: Control group: Patients will orally take one 500 mg capsule of the placebo (contains toasted flour) produced by the Medicinal Plants Research Center of Jihad Daneshghani, every 12 hours after meals for a period of 2 months. 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 further information
public Fallah Huseini Hasan
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 h.fallah@acecr.ac.ir Iranian academic center for education culture and research scientific Reza Mohtashami
Bagheiat-allah University of Medical Sciences, Molasadra Ave., Vanak square
Tehran Iran (Islamic Republic of) 1484958693 +98 21 8806 8923 reza_mohtashami1979@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with osteoarthritis visit to Baqiyatallah Hospital in Tehran Male or female patients aged 40 to 80 years According to the criteria of the American College of Rheumatology Patients with Knees osteoarthritis grade 1 or 2 40 years 80 years Both Patients with history of arthroscopy, surgery, or Injection to the target knee joint within the past 6 months History of knee replacement Any serious systemic disease (such as secondary infections and cardiovascular, liver, and kidney diseases) or any other chronic inflammatory disease Any history of alcohol and drug abuse Patients with fibromyalgia and other debilitating diseases affecting the knees Blood clotting disorders, and or use of anticoagulants such as warfarin and heparin Use of anti-platelet drugs such as aspirin, and thrombolytic drugs Pregnant women, women who are planning to have children, and women who are breastfeeding are not included in the plan. M19.9 Osteoarthritis, unspecified site Treatment - Drugs Placebo Intervention group: Patients will orally take one 500 mg capsule of the herbal mixture (Curcuma longa, Piper nigrum and Camellia sinensis) produced by the Medicinal Plants Research Center of Jihad Daneshghani, every 12 hours after meals for a period of 2 months. Control group: Patients will orally take one 500 mg capsule of the placebo (contains toasted flour) produced by the Medicinal Plants Research Center of Jihad Daneshghani, every 12 hours after meals for a period of 2 months. Joint pain. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The Visual Analogue Scale Questionnaire. Joint stiffness. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire. Physical activity. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire. Dose of acetaminophen used. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire. Blood urea nitrogen. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The level of urea nitrogen in the blood is measured by an autoanalyzer in the laboratory. Creatinine. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The level of creatinine in the blood is measured by an autoanalyzer in the laboratory. Aspartate aminotransferase. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The level of aspartate aminotransferase in the blood is measured by an autoanalyzer in the laboratory. Alanine aminotransferase. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The level of alanine aminotransferase in the blood is measured by an autoanalyzer in the laboratory. Blood cell count. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: Blood cell counts are measured in the laboratory using a cell counter. Severity of arthritis. Timepoint: Before intervention and end of intervention after 2 months. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire. Iranian academic center for education culture and research Approved 2026-02-01 Research Ethics committee of Baghiatallah Hospital Baqiyatallah University of Medical Sciences, Molasadra Ave, Vanak Square Tehran Tehran Iran (Islamic Republic of)