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Title: Efficacy and safety of RA-11 (O) – A herbal analgesic cream
Authors: Wadnap, Neelesh
Johnson, Jasmin
Bhatt, Narendra
Chitre, Deepa
Keywords: Ayurvedic cream;Analgesic cream;Antiinflammatory cream;Herbal cream;Joints pain;Swelling
Issue Date: Jul-2006
Publisher: CSIR
IPC Code: Int. Cl.8: A61K36/00,A61P7/10, A61P19/00, A61P19/02, A61P19/06, A61P21/00, A61P29/00, A61P19/02
Abstract: The plant based multi-component formulation; RA-11 (O) has been conceived and developed from Ayurvedic science for topical application in patients with joints pain and swelling. The clinical study was undertaken to test the safety and efficacy of RA-11 (O). Thirty patients, who had joints pain and swelling, with restriction of movement, and were able to understand and sign the informed consent form, were included in the study. The patients were advised to apply the study drug thrice daily for 14 days. There was significant reduction in the Visual Analog Scale score for joints pain on 7th and 14th day (p<0.001). The physician’s assessment of disease showed improvement with 9 patients being a symptomatic on 7th day of treatment and 25 patients being a symptomatic on 14th day of treatment. The patient’s assessment of disease showed a similar resolution of symptoms with 6 patients noting no symptoms on 7th day of treatment (p<0.01) and 23 patients being a symptomatic on 14th day of treatment (p<0.001). Body weight and vital parameters were unaffected over the course of the study. Skin irritation test showed no irritation in any of the patients and no dermal side effects were observed on follow up over 14 days. The domains of pain, freedom of movement and global assessment, which are the core variables in any study of joints pain and swelling; showed significant improvement in the study. RA-11 (O) has been reported as a safe and effective topical cream for relief of joints pain and swelling.
Page(s): 384-387
ISSN: 0975-1068 (Online); 0972-5938 (Print)
Appears in Collections:IJTK Vol.05(3) [July 2006]

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