Evidence map›Paper›PMID 32110566›Full record

ArticleJournal of family medicine and primary care2020

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

Sanjay U Nipanikar, Shailesh Deshpande, Ashutosh H Bhosale, Mayura V Jadhav-Shinde

Open access · goldAbstract read
In one paragraph

Article in Journal of family medicine and primary care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Sanjay U NipanikarMedical 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.
Shailesh DeshpandeDepartment of Kayachikitsa, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India.
Ashutosh H BhosaleDepartment of Orthopedic Surgery, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India.
Mayura V Jadhav-ShindeDepartment of Panchakarma, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India.
Government Ayurved College, Nanded · INBiotech Park · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteoarthritis (OA) is the most common form of arthritis with unsatisfactory treatment outcomes.

objectivesTo evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects with OA of knee joint. STUDY

designProspective, open-label, single-arm clinical study conducted in daily clinical practice setting.

methodSubjects 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.

resultsAt 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.

Indexed as

AHPL/AYTAB/0313clinical studymobilityosteoarthritis of kneeVASWOMAC

Identifiers

PMID32110566
PMCPMC7014886
OpenAlexW3004138425

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.