A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWAGANDHADYA GHRITA PANA AND NASYA ALONG WITH RASNAPANCHAK KWATHA AND GUGGULU VATI IN MANAGEMENT OF CERVICAL SPONDYLOSIS (GREEVA SANDHIGATAVATA)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study will be the change in Neck Disability Index Score
Study Overview
Brief Summary
The study titled "A Randomized Comparative Clinical Study to Evaluate the Efficacy of Ashwagandhadya Ghrita Pana and Nasya along with Rasnapanchak Kwatha and Guggulu Vati in Cervical Spondylosis (Greeva Sandhigatavata)" is a postgraduate research project in Ayurveda.BackgroundCervical Spondylosis is a degenerative condition affecting the cervical spine, leading to neck pain, stiffness, and neurological complications. The study correlates this condition with Greeva Sandhigata Vata in Ayurveda and aims to explore the effectiveness of Ayurvedic treatments for pain relief and functional improvement.
I. Null Hypothesis [Ho]- There is no difference between the efficacy of Ashwagandhadya ghritapana and nasya along with Rasnapanchak kwatha and Guggulu Vati in Cervical Spondylosis
II. Alternative Hypothesis [HA]- There is difference between the efficacy of Ashwagandhadya ghritapana and nasya along with Rasnapanchak kwatha and Guggulu Vati in Cervical Spondylosis
Study Design
- Type: Randomized, Comparative Clinical Trial
- Participants: 40 patients (30–70 years) diagnosed with Cervical Spondylosis
- Groups:
- Group A: Ashwagandhadya Ghrita Pana, Guggulu Vati, and Rasnapanchak Kwatha
- Group B: Ashwagandhadya Ghrita Nasya, Guggulu Vati, and Rasnapanchak Kwatha
- Duration: 28 days with follow-up after 1 month
Treatment & Methodology
- Ashwagandhadya Ghrita is used for its Vata-balancing and Brimhana properties.
- Guggulu Vati supports joint health and reduces inflammation.
- Rasnapanchak Kwatha relieves pain, strengthens muscles, and improves digestion.
- Efficacy is measured using the Neck Disability Index (NDI), pain scales, and radiological findings.
Outcome & SignificanceThe study aims to provide scientific evidence on Ayurvedic treatments as an alternative to conventional therapies, reducing dependency on NSAIDs and steroids while improving patients’ quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender having age between 30-70 years
- •Patients with clinical signs and symptoms of Greeva sandhigata vata (Cervical Spondylosis)
- •Patients having a radiological finding of Cervical Spondylosis
- •Patients fit for Nasya karma and Snehapana.
Exclusion Criteria
- •Recent cervical, spinal, or shoulder trauma or surgery or any implantation in these sites
- •History of Cervical Spondylotic Myelopathy, Cervical Rib, severe Cervical Radiculopathy
- •Patients having systemic illness such as Ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, inflammatory arthritis
- •Patients having suspected TB or HIV infection, vascular insufficiency or malignancy
- •Pregnant or lactating women
- •Patients having known allergy to any of the trial drug.
Outcomes
Primary Outcomes
The primary outcome of the study will be the change in Neck Disability Index Score
Time Frame: At baseline and after four weeks
Secondary Outcomes
- Secondary outcomes will include changes in scoring of subjective parameters assessing pain, neck stiffness and active neck movements (From baseline to the end of the treatment period)(After four weeks)
Investigators
RACHNA SHARMA
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR