World Rural Health Conference
Home Print this page Email this page Small font size Default font size Increase font size
Users Online: 6708
Home About us Editorial board Search Ahead of print Current issue Archives Submit article Instructions Subscribe Contacts Login 
ORIGINAL ARTICLE
Year : 2020  |  Volume : 9  |  Issue : 1  |  Page : 61-68

A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects suffering from osteoarthritis of knee(s)


1 Medical Services Department, Head R and D, Ari Healthcare Pvt. Lt, Unit No.-401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th Floor, Plot No. 2A, MIDC, PhaseII, Hinjewadi, Maharashtra, India
2 Department of Kayachikitsa, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India
3 Department of Orthopedic Surgery, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India
4 Department of Panchakarma, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India

Correspondence Address:
Dr. Sanjay U Nipanikar
Services Department, Head R and D, Ari Healthcare Pvt. Lt, Unit No.401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th Floor, Plot No.2A, MIDC, PhaseII, Hinjewadi, Pune, Maharashtra - 411 057
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jfmpc.jfmpc_321_18

Rights and Permissions

Background: Osteoarthritis (OA) is the most common form of arthritis with unsatisfactory treatment outcomes. Objectives: To evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects with OA of knee joint. Study Design: Prospective, open-label, single-arm clinical study conducted in daily clinical practice setting. Method: Subjects were advised to take 2 AHPL/AYTAB/0313 tablets twice daily orally after meals for 180 days. 48 subjects completed the study. The primary endpoints were changes in mean visual analogue scale (VAS) pain score and WOMAC score. Secondary endpoints were quality of life, time to walk 50 feet, knee joint swelling, use of analgesic drug as rescue medicine, and safety parameters. Results: At baseline visit, the mean index knee joint pain (VAS) score was 82.29 ± 15.19, which reduced significantly to 19.38 ± 13.75 on day 180. The mean WOMAC combined score at baseline was 39.94 ± 11.67, which reduced significantly to 09.58 ± 05.77 (76.0%) on day 180. The mean WOMAC pain score at baseline was 09.65 ± 02.91, which reduced significantly to 02.06 ± 01.46 on day 180. The mean WOMAC stiffness score at baseline was 03.48 ± 01.58, which reduced significantly to 00.63 ± 01.08 on day 180. The mean WOMAC difficulty score at baseline was 26.81 ± 09.63, which reduced significantly to 06.90 ± 04.78 on day 180. The mean walking time to walk 50 feet reduced significantly by 40% on day 180. Not a single subject was known to have knee joint swelling from 150 days onwards. Only 5 subjects were using analgesic as rescue medicine on day 180. Twenty-six subjects had adverse events (AEs). Most of the AEs were not associated with the study medication. Vitals and all the safety laboratory parameters were within normal limits both at baseline and on day 180. Conclusion: “AHPL/AYTOP/0113” tablet is safe and significantly effective in reducing pain, swelling, and stiffness of knee joints and improving mobility of knee joints in patients with OA. CTRI registration No. is CTRI/2015/09/006177.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed368    
    Printed1    
    Emailed0    
    PDF Downloaded33    
    Comments [Add]    

Recommend this journal