"An Open labelled non randomised phase II clinical trial to evaluate the effectiveness of SAGALAVAYU OTTRADAM(external therapy)in the management of Cervical spondylosis"

Phase 2

Not yet recruiting

• Conditions: Other spondylosis,

• Registration Number: CTRI/2025/05/086135
• Lead Sponsor: Dr A PUSHPALATHA

Brief Summary

This study is an open labelled non-randomized phase II clinical trial to evaluate the efficacy of

SAGALAVAYU OTTRADAM an external therapy in the management of CEGANA VATHAM( CERVICAL SPONDYLOSIS )The trial drug will be

an external application for 29- 30 minutes for 7 days repeat with 2 such course with an interval of 5 days in between each course for 40 patients.The trial period of 24 months will be

carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002,

Tamilnadu.The outcome will be an external therapy in SAGALAVAYU OTTRADAM towards the management of

CEGANA VATHAM (CERVICAL SPONDYLOSIS) and expect the patients to be relieved from the symptom.In case of any

adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further

management of patients will be given OPD patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-21
• Study Start: 2025-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Pain present in the neck region radiating to the back of head, top of shoulder, shoulder blades, upper limbs.with or without numbness in the upper limbs, giddiness and neck stiffness,patient who are willing for admission and stay in IPD or willing to attend OPD.partciants with mild and moderate symptoms.

Exclusion Criteria

Recent history of Trauma and fracture, dislocation of cervical vertebra and surgery cord compression Tuberculosis in spine & pyogenic bone infection Spondylolisthesis and ankylosing spondylitis Auto immune diseases like RA, SLE, psoriatic arthritis and mixed connective tissue disorders Tuberculous arthritis Cervical myelopathy Cervical rib Torticollis (wry neck) Osteochondritis Tumour in vertebral body Meningitis Participants who need internal medicine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study will help to understand the effectiveness of external therapy SAGALAVAYU OTTRADAM towards the management of CEGANA VATHAM (CERVICAL SPONDYLOSIS). Prognosis of CEGANA VATHAM and improvement in the patients quality of life will be assessed and documented.	31 days

Trial Locations

Locations (1)

Government siddha medical College and hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government siddha medical College and hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Dr A PUSHPALATHA

Principal investigator

7010050895

pushpalathaamirthalingam@gmail.com