Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial.
BACKGROUND
AmrutBhallatak (ABFN02), a 'rasayana' drug from Ayurveda is indicated in degenerative diseases and arthritis.


OBJECTIVE
To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA) and compare it with Glucosamine sulphate (GS).


METHODS
This was a randomized open comparative study. Ambulant OPD patients of OA knees (n = 112) were enrolled for 24 weeks. Tablets (750mg each) of GS and ABFN02 were matched. Three groups of patients: (A) GS, one tablet × twice/day × 24 weeks. (B) ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks), two such cycles of drug and non-drug phases alternately for six weeks each (C) ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS) and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC) were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ), paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients.


RESULTS
ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group.


CONCLUSIONS
ABFN02 has significant activity in OA; the formulation needs further investigation.
Medical Research Center of Kasturba Health Society, Vile Parle, Mumbai, Maharashtra, India.
Ashwinikumar
A
Raut
Department of Medicine King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
Lata
L
Bichile
Center for Rheumatic Diseases, Pune University, Pune, Maharashtra, India.
Arvind
A
Chopra
Interdisciplinary School of Health Sciences, Pune University, Pune, Maharashtra, India.
Bhushan
B
Patwardhan
Medical Research Center of Kasturba Health Society, Vile Parle, Mumbai, Maharashtra, India.
Ashok
A
Vaidya
Ayurveda; Bhallatak; Rasayana; Semecrpus anacardium; Tinospora cordifolia; reverse pharmacology