EVALUATION OF THE THERAPEUTIC EFFECTIVENESS OF KODUVELI NEI AND VARMAM THERAPY IN THE MANAGEMENT OF THANDAGA VAATHAM (LUMBAR SPONDYLOSIS) - PRE-CLINICAL AND CLINICAL STUDY

The aim of the study is to evaluate the preclinical safety, efficacy and therapeutic effectiveness of Koduveli nei and Varmam therapy in the management of Thandaga vaatham (Lumbar spondylosis) with the Oswestry low back disability questionnaire scoring 5 - 34 through randomized controlled clinical trial. After completing the acute and sub-acute toxicity studies of the trial drug, 138 selected patients will be allotted in the study group 1, 2 and 3 through computer generated randomization and envelope concealment allocation method. Before starting the treatment, purgation with Agasthiyar kulumbu – 130 mg at early morning in empty stomach with inji saaru (Ginger juice) will be given for balancing the deranged Uyir thathu and advised to take rest on next day. For Group 1 patients, the patient is treated with Koduveli nei internally for 9 days and then advised patient advised to take oil bath and pathiyam. Followed by this, the Varmam therapy will be given for the patients for 15 days. For Group 2 patients, the Varmam therapy will be given for the patients for 28 days.For Group 3 patients, Arumuga chenduram (internally) and Laguvidamusti thylam (externally) is given. The patients who fail to come regularly for more than 3 days will not be allowed to continue the trial and withdrawn from the study. Weekly once, the clinical assessment and prognosis will be noted in the prescribed proformas. The assessment and other clinical data capturing will be done in the presence of guide and in the supervision of Head of the Department. Laboratory Investigations and Oswestry low back disability Questionnaire will be performed before and after the trial. After the completion of trial period the patients will be advised to visit the OPD for further followup for two months.