STUDY ENROLLMENT:

Patients reporting at the OPD with clinical features of pain in nape radiating to upper limbs, stiffness are chosen for enrollment based on the inclusion criteria.

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

All these patients will be given unique registration card in which the patients Registration number of the study, Address, Phone number and Doctors phonenumber etc. will be given, so as to report easily if any complications arise.

Complete clinical history, complaints, duration, examination findings and laboratory investigations will be recorded in the prescribed Proforma.

Screening Form- I will be filled up: Form - III , Form - IV and Form - V will be used for recording the patients history, clinical examination of symptoms, signs and laboratory investigations respectively. Patients will be advised to take the trial drug and appropriate dietary advice would be given according to the patients’ perfect understanding.

CONDUCT OF THE STUDY:

On the first day of the treatment Purgation will be given with Vellai Ennai-15 ml earlymorning for balancing the deranged thathus. The next day onwards the trial drugs VALLADHI RASAYANAM(Internal) and SARVANGA VATHATHYLAM (External)will be given for 12 days.

          Dietary advice 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 is done 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  for both OP & IP patients.

           For IP patients, who is not in a situation to stay in the hospital for a long 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 the OPD  for another 2months for follow-up. If any trial patient who fails to collect the trial drug on the prescribed day but wants to continue in the trial from the next day or two, he/ she will be allowed, but defaulters of one week and more will not be allowed to continue and be withdrawn from the study with fresh case being included.

DATA ANALYSIS:

After enrolling the patients in the study, a separate file for each patient 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 easy identification. Whenever the patient visits OPD during the study period, necessary entries will be made at the assessment forms.

The screening forms will be filled up separately.

The data entries and adverse events, of any, will be monitored by the Head of the Department and Pharmacovigilance cell. All forms will be further scrutinized by Sr. Research Officer (Statistics) for logical errors and incompleteness of data to avoid any bias. No modification in the results is permitted for unbiased reports.