study of Treatment of Cervical Spondylosis by Ayurvedic drug

Phase 2

Completed

• Conditions: Patients Suffering From Cervical Spondylosis (Greevagraha)

• Registration Number: CTRI/2017/11/010410
• Lead Sponsor: Ceneral Council For Research In Ayurvedic SciencesCCRAS

Brief Summary

Thisstudy is an IMR Project under CCRAS Ministry of Ayush, New Delhi. This issingle group open label prospective interventional uni-centric (RARINDMANDI,H.P. INDIA) study to evaluate the efficacy of PANCHAMRIT LAUHA GUGGULUand PANCHGUNA TAILA in the Management of GREEVA GRAHA (CERVICAL SPONDYLOSIS).The primary outcome measures will be relief in signs and symptoms (pain andassociated complaints) of the disease by reduction in the Northwick Park NeckPain questionnaire after every 14 days upto at the end of 98th day.The secondary outcome measures will be improvement in health status by SF36Questionnaire (RAND 36) at the baseline, at the end of 12 weeks and at the end offollow up (2 weeks).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Study Completion: 2019-11-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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, Pott’s disease etc.
• 4.Patients with congenital cervical rib and acquired Spinal deformity(Pott’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.
• 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

Name	Time	Method
Relief in Signs & Symptoms (pain and associated complaints) of the disease by reduction in the Northwick Park Neck Pain questionnaire	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

Name	Time	Method
Improvement in health status by SF 36 Questionnaire(Rand-36)	Basline and at the end of 12 weeks and follow up at the end of 2 weeks

Trial Locations

Locations (1)

Regional Ayurveda Research Institute For Nutritional Disorders; 🇮🇳 Mandi, HIMACHAL PRADESH, India

Regional Ayurveda Research Institute For Nutritional Disorders

🇮🇳Mandi, HIMACHAL PRADESH, India

Dr Om Raj Sharma

Principal investigator

9418062731

arri.mandi@gmail.com