An open clinical study to evaluate the efficacy of Siddha Polyherbal Medicine Valladhi Rasayanam[Internal],Sarvanga Vatha Thylam[External] and Ottradam[External Therapy] for the treatment of Cegana Vatham[Cervical Spondylosis]

STUDY ENROLLMENT:

Patients reporting at the OPD with clinical featuresof pain in nape radiating to upper limbs, stiffness are chosen for enrollmentbased on the inclusion criteria.

The patients who are enrolled will be informed aboutthe study, trial drug, possible outcomes and the objectives of the study in thelanguage and terms understandable to them and theinformed consent would beobtained in writing from them in the consent form (Form II).

Allthese patients will be given unique registration card in which the patientsRegistration number of the study, Address, Phone number and Doctors phonenumberetc. will be given, so as to report easily if any complications arise.

Completeclinical history, complaints, duration, examination findings and laboratory investigationswill be recorded in the prescribed Proforma.

ScreeningForm- I will be filled up: Form - III , Form - IV and Form - V will be used forrecording the patients history, clinical examination of symptoms, signs andlaboratory investigations respectively. Patients will be advised to take thetrial drug and appropriate dietary advice would be given according to thepatients’ perfect understanding.

CONDUCT OF THE STUDY:

On the first day of the treatment Purgation will begiven with Vellai Ennai-15 ml earlymorning for balancing the deranged thathus.The next day onwards the trial drugs VALLADHIRASAYANAM(Internal) and **SARVANGAVATHATHYLAM (**External)will be givenfor 12 days.

Dietaryadvice is strictly followed during the period of drug administration .

For OP patients ,they should visit the hospital once in 4 days.  At each clinical visit clinical assessment isdone and prognosis is noted.

For IP patients clinical assessment is daily and prognosis is noted.

Laboratory investigations &radiological  investigation are done  0day ,6th & 13th day of the trial  forboth OP & IP patients.

For IP patients, who is not in a situation to stay in the hospital for along time is advised to attend the OPD for the continuation of the treatment.After the end of the treatment also, the patient is advised to visit theOPD  for another 2months for follow-up.If any trial patient who fails to collect the trial drug on the prescribed daybut wants to continue in the trial from the next day or two, he/ she will beallowed, but defaulters of one week and more will not be allowed to continue andbe withdrawn from the study with fresh case being included.

DATA ANALYSIS:

After enrolling the patients in the study, a separate file for eachpatient will be maintained and all forms will be kept in the file. Study No.and patient’s No. will be entered on the top of the file for easyidentification. Whenever the patient visits OPD during the study period,necessary entries will be made at the assessment forms.

The screeningforms will be filled up separately.

The dataentries and adverse events, of any, will be monitored by the Head of theDepartment and Pharmacovigilance cell. All forms will be further scrutinized bySr. Research Officer (Statistics) for logical errors and incompleteness of datato avoid any bias. No modification in the results is permitted for unbiasedreports.