MedPath

study of Treatment of Cervical Spondylosis by Ayurvedic drug

Phase 2
Completed
Conditions
Health Condition 1: null- Patients Suffering From Cervical Spondylosis (Greevagraha)
Registration Number
CTRI/2017/11/010410
Lead Sponsor
Ceneral Council For Research In Ayurvedic SciencesCCRAS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
63
Inclusion Criteria

1.Patients of either sex with age between 30 and 60 years.

2.MRI Neck, findings suggestive of degenerative changes & cervical spondylosis.

3.Patients with or without radiculopathy.

4.Intermittent neck and shoulder pain.

5.Restricted movement of neck.

Exclusion Criteria

1.Age below 30 years and above 60 years

2.Patients with cervical myelopathy.

3.Patients with neck pain and other degenerative signs due to other reasons like spondylolysthesis, cervical spinal stenosis, diseases of atlanto-occipital joint, meningitis, atlantoaxial joint, muscle strain or soft tissue etiology, pregnancy, tumours, internal bleeding(haematoma)infection, injury, Pottâ??s disease etc.

4.Patients with congenital cervical rib and acquired Spinal deformity(Pottâ??s fracture, compression fracture etc)

5.Patients with poorly controlled Hypertension ( >160/100 mmHg)

6. Patients with uncontrolled Diabetes Mellitus having Hb A1C of > 8%

7.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.

8.Known cases of cardiovascular diseases, hepatic disorders, Renal Disorders, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Malignancy or any other condition that may jeopardize the study.

9. Alcoholics and/or drug abusers/ chain smokers.

10.Chronic Rheumatological and auto-immune diseases like RA, Psoriatic arthropathy, Gout, SLE.

11.H/o hypersensitivity to any of the trial drugs or their ingredients.

12.Patients who have completed participation in any other clinical trial during the past six months

13.Any other condition which the Investigator thinks may jeopardize the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relief in Signs & Symptoms (pain and associated complaints) of the disease by reduction in the Northwick Park Neck Pain questionnaireTimepoint: Relief in Signs & Symptoms (pain and associated complaints) of the disease by reduction in the Northwick Park Neck Pain questionnaire after every 14 Days upto at the end of 98th day.
Secondary Outcome Measures
NameTimeMethod
Improvement in health status by SF 36 Questionnaire(Rand-36)Timepoint: Basline and at the end of 12 weeks and follow up at the end of 2 weeks
© Copyright 2025. All Rights Reserved by MedPath