A randomized, double‐blind placebo‐controlled phase I clinical study on safety and efficacy of the G‐Rup® syrup (a mixture of ginger extract and honey) in symptomatic treatment of knee osteoarthritis

What is known and Objectives Present study evaluated the safety profile and efficacy of G‐Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in symptomatic treatment of knee osteoarthritis (OA). Methods Patients diagnosed with knee OA were randomly assigned (1:1) to receive either of a 30 ml...

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Bibliographic Details
Published in:	Journal of clinical pharmacy and therapeutics Vol. 47; no. 12; pp. 2295 - 2301
Main Authors:	Afshar, Fariba, Abdolahi, Nafiseh, Amin, Gholamreza, Esmaily, Hadi, Ziayie, Shadi, Azimi, Saeed, Darvishi, Behnam, Afshar, Shima
Format:	Journal Article
Language:	English
Published:	England Hindawi Limited 01-12-2022
Subjects:	Arthritis Double-Blind Method Double-blind studies ginger Honey Humans integrative medicine Knee Osteoarthritis Osteoarthritis, Knee - chemically induced Osteoarthritis, Knee - drug therapy Pain Pain - drug therapy Patients Persian medicine Placebos Plant Extracts - adverse effects Safety Syrups Treatment Outcome WOMAC Zingiber officinale pain integrative medicine ginger honey osteoarthritis WOMAC Persian medicine Zingiber officinale
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Summary:	What is known and Objectives Present study evaluated the safety profile and efficacy of G‐Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in symptomatic treatment of knee osteoarthritis (OA). Methods Patients diagnosed with knee OA were randomly assigned (1:1) to receive either of a 30 ml twice daily regimen of G‐Rup® syrup or placebo over a 12‐week period. Primary endpoints of the study comprised of an improvement in the joint's stiffness, physical functioning and pain score, assessed by WOMAC questionnaire and the visual analog scale (VAS). Secondary objectives comprised of safety and tolerability of the syrup by patients. Results and discussion The 30 ml twice‐daily regimen of G‐Rup® syrup was safe and well tolerated by patients. Moreover, in whole studied time points, treatment with G‐Rup® syrup could significantly Power the VAS score (p < 0.001) whereas improving WOMAC total score (p < 0.001) and pain (p < 0.001), physical functioning (p < 0.001), and stiffness sub‐scores (p = 0.006) compared to the placebo receiving group. What is new and Conclusion Based on obtained results, the G‐Rup® syrup, composed of a combination of honey and ginger, may be a proper supplementary choice, along with routine therapeutic regimens, for improvement of symptomatic treatment of OA. Present study represents significant anti‐arthritis rheumatoid effects of G‐Rup® syrup G‐Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in patients. Treatment with G‐Rup® syrup could significantly lower the VAS score (p < 0.001) whereas improving WOMAC total score (p < 0.001) and pain (p < 0.001), physical functioning (p < 0.001), and stiffness sub‐scores (p = 0.006) compared to the placebo receiving group.
Bibliography:	Funding information YAS Daru Pharmaceutical Company ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0269-4727 1365-2710
DOI:	10.1111/jcpt.13812