Clinical study on Ayuartis Capsule in arthritis of Neck

Phase 2/3

Completed

Brief Summary: **It is a randomized, double blind, placebocontrolled, comparative, interventional, multi-centric, prospective, clinicalstudy to evaluate efficacy and safety of Ayuartis Capsule in patients sufferingfrom cervical spondylitis. The study will be conducted at three sites in India.As per computer generated randomization list, subject will be either randomizedto drug group or placebo group in 1:1 ratio. Subjects will be advised to takegiven medication in a dose of 2 capsules twice daily orally after meals withwater for 90 days. The primary objective of the study will be to assess changein neck disability index (NDI) from baseline to end of study visit (comparisonbetween the groups). The secondary objectives will be to assess change in neckpain using visual analogue scale (VAS) from baseline to end of study visit(comparison between the groups), change in tenderness, difficulty in neckmovement, vertigo, imbalance, nausea, limited ROM in shoulder joints andparaesthesia in upper extremities using likert scale from baseline to end ofstudy visit (Comparison between the groups), use of rescue medication frombaseline to end of study visit (comparison between the groups), globalassessment for overall change by the subject and investigator at the end ofstudy treatment and tolerability of study drugs by assessing adverse events/ adversedrug reactions, laboratory parameters, and ECG on study completion.**

Recruitment & Eligibility

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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Change in neck pain using VAS	2. Change in tenderness, difficulty in neck movement, vertigo, imbalance, nausea, limited ROM in shoulder joints and paraesthesia in upper extremities using likert scale

Locations (3): Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳
Nashik, MAHARASHTRA, India
Khemdas Ayurved Hospital
🇮🇳
Vadodara, GUJARAT, India
KVTR Ayurvedic College
🇮🇳
Dhule, MAHARASHTRA, India
Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳Nashik, MAHARASHTRA, India
Dr Shishr Pande
Principal investigator
9420830818
shishir.nsk@gmail.com