A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF CHITRAMOOLA ENNAI IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS)

This is a“A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF CHITRAMOOLA ENNAI IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS) after purification of trial drug CHITRAMOOLA ENNAI is prepared and administered at the dosage of 4 grams for 40 days which is given to 40 known lumbar spondylosis patient (20 OP+20 IP patients).The primary outcome will be determine the therapeutic efficacy of CHITRAMOOLA ENNAI in the management of thandaga vatham (Lumbar spondylosis).The secondary out come will be to collect various siddha literatures on THANDAGAVATHAM to perform physicochemical ,phytochemical,biochemical analysis of CHITRAMOOLA ENNAI to evaluate safety profile for acute and sub-acute toxicity of CHITRAMOOLA ENNAI to evaluate pharmacological activities of CHITRAMOOLA ENNAI  to study about the prevalence of THANDAGAVATHAM in  relationship with diet and lifestyle ,to evaluate siddha parameters(including Envagaithervu ,Neerkuri - Neikuri) changes and dhegi of THANDAGAVATHAM patients during trail period ,to evaluate modern parametric changes in THANDAGAVATHAM to assess the quality of life of THANDAGAVATHAM  patients and to document Bio statistical analysis .