Clinical study on Ayuartis Capsule in arthritis of Neck

Phase 2

Completed

Conditions: Health Condition 1: M509- Cervical disc disorder, unspecified

Registration Number: CTRI/2019/11/021883

Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects having Neck Pain with or without radicular symptoms (paraestheÂ¬sia) since more than 2 months

2.Cervical spondylitis confirmed by radiological assessment (x-ray cervical vertebrae AP and Lateral view)

3.Subjects who are willing to give informed consent and ready to comply with the protocol.

4.Subjects who are ready to provide regular follow ups till the completion of the Study

Exclusion Criteria

1.Known cases of trauma of neck, wry neck, vertebro basilar insufficiency, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylitis, myelopathy and carpal tunnel syndrome

2.Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper Limb

3.Known cases of Rheumatoid arthritis

4.Severe Osteoporosis as reported in cervical X Ray

5.Signs of nerve root compression of C1-C8, such as severe paresis, muscle loss, hyporeflexia,

6.Subjects with current use of steroidal medication prescribed for radiculopathy symptoms.

7.Subjects who use any other investigational drug within 1 month prior to randomization;

8.Known cases of tuberculosis, HIV, Ischemic Heart Disease, Cancer, uncontrolled hypertension, uncontrolled diabetes mellitus,

9.Pregnancy & Lactation.

10.Known hypersensitivity to ingredients used in study drug

11.Subjects with significant abnormal laboratory parameters

12.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in neck disability index (NDI) from baseline to end of study visit (comparison between the groups)Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1. Change in neck pain using VAS <br/ ><br>2. Change in tenderness, difficulty in neck movement, vertigo, imbalance, nausea, limited ROM in shoulder joints and paraesthesia in upper extremities using likert scale <br/ ><br>3. Assessment of use of rescue medication <br/ ><br>4. Global assessment for overall change by the subject and investigator <br/ ><br>5. Tolerability of study drugs by assessing adverse events, laboratory parameters, and ECG. <br/ ><br>Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90