Document Type : Original Research Article
Authors
1
Department of Persian Medicine, Faculty of Persian Medicine, Tehran University of Medical Sciences, Ahmadieh Health Center, No. 27, st. north sarparst, West of Taleghani Street, Phelestine Square, Tehran, Iran
2
1.Department of Iranian Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, 2.Food Microbiology Research Center, Tehran University of Medical Sciences (TUMS), Tehran, Iran
3
Department of Public Health, School of Public Health, Zanjan University of Medical Sciences
4
Department of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran
5
Department of Internal Medicine, School of Medicine, Vali-e-Asr Hospital, Zanjan University of Medical Sciences
6
Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran
7
Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences (TUMS), Tehran, Iran
8
Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
10.22038/ajp.2026.27962
Abstract
Objective: Knee osteoarthritis (KOA) is the most prevalent debilitating joint disorder worldwide, with limited effective and treatment options. Traditional medicines may help discover more effective and safer pharmacological treatments. This study was designed to evaluate the efficacy and safety of “Dava-e Balgham” (DB), a Persian Medicine (PM) herbal formula, in KOA patients.
Materials and Methods: The present trial was conducted in Shariati Hospital, Tehran, Iran, from August 2020 to June 2022. A total of 110 patients with KOA were randomly allocated to intervention or placebo (toast powder) groups. The intervention group received the Dava-e Balgham capsule three times daily for 8 weeks. Capsules were filled with powders of Nigella sativa, Trachyspermum ammi, Zataria multiflora, and Pistacia atlantica oleoresin. Participants were followed up to 16 weeks. The primary outcome was the severity of knee pain, while other OA symptoms, activity, sport, and quality of life were considered secondary outcomes.
Results: A total of 110 patients were enrolled, of whom, 99 completed the trial (mean age: 58 ±9.8 years). The DB formulation significantly improved KOA symptoms compared to the placebo. For the primary outcome, the between-group mean difference in KOOS Pain score change from baseline to week 8 was 15.06 points. The corresponding between-group mean differences in score change for other symptoms, activities of daily living, sport/recreation, and quality of life were 12.34, 13.66, 12.46, and 14.42 points, respectively. No considerable treatment-related adverse effects were reported.
Conclusion: The present study supports the use of the PM formula, DB, as an adjuvant treatment for KOA.
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