PMID- 32110566
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220413
IS  - 2249-4863 (Print)
IS  - 2278-7135 (Electronic)
IS  - 2249-4863 (Linking)
VI  - 9
IP  - 1
DP  - 2020 Jan
TI  - A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in 
      subjects suffering from osteoarthritis of knee(s).
PG  - 61-68
LID - 10.4103/jfmpc.jfmpc_321_18 [doi]
AB  - 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.
CI  - Copyright: (c) 2020 Journal of Family Medicine and Primary Care.
FAU - Nipanikar, Sanjay U
AU  - Nipanikar SU
AD  - 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.
FAU - Deshpande, Shailesh
AU  - Deshpande S
AD  - Department of Kayachikitsa, Pune District Education Association's, College of 
      Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, 
      Pune, Maharashtra, India.
FAU - Bhosale, Ashutosh H
AU  - Bhosale AH
AD  - 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.
FAU - Jadhav-Shinde, Mayura V
AU  - Jadhav-Shinde MV
AD  - Department of Panchakarma, Pune District Education Association's, College of 
      Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, 
      Pune, Maharashtra, India.
LA  - eng
PT  - Journal Article
DEP - 20200128
PL  - India
TA  - J Family Med Prim Care
JT  - Journal of family medicine and primary care
JID - 101610082
PMC - PMC7014886
OTO - NOTNLM
OT  - AHPL/AYTAB/0313
OT  - VAS
OT  - WOMAC
OT  - clinical study
OT  - mobility
OT  - osteoarthritis of knee
COIS- There are no conflicts of interest.
EDAT- 2020/02/29 06:00
MHDA- 2020/02/29 06:01
PMCR- 2020/01/28
CRDT- 2020/02/29 06:00
PHST- 2018/10/09 00:00 [received]
PHST- 2019/12/13 00:00 [revised]
PHST- 2019/12/16 00:00 [accepted]
PHST- 2020/02/29 06:00 [entrez]
PHST- 2020/02/29 06:00 [pubmed]
PHST- 2020/02/29 06:01 [medline]
PHST- 2020/01/28 00:00 [pmc-release]
AID - JFMPC-9-61 [pii]
AID - 10.4103/jfmpc.jfmpc_321_18 [doi]
PST - epublish
SO  - J Family Med Prim Care. 2020 Jan 28;9(1):61-68. doi: 10.4103/jfmpc.jfmpc_321_18. 
      eCollection 2020 Jan.