| CTRI Number |
CTRI/2026/01/100582 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two Ayurvedic nasal therapies with external treatments for reducing neck pain and disability in patients with cervical spondylosis |
|
Scientific Title of Study
|
A Randomised Open-Label Comparative Clinical Study to Evaluate the Efficacy of ‘Nasya Karma with Upanaha’ and ‘Nasya Karma with Jambira
Pinda Swedana’ in the Management of Cervical Spondylosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Goel |
| Designation |
MD SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,
Ajmal Khan Road, Karol Bagh, Delhi – 110005
Central
DELHI
110005
India |
| Phone |
7982617449 |
| Fax |
|
| Email |
goelakash500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin Jindal |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma,
Ayurvedic and Unani Tibbia College and Hospital,
Ajmal Khan Road, Karol Bagh, Delhi – 110005
Central
DELHI
110005
India |
| Phone |
9811765501 |
| Fax |
|
| Email |
nitjin2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akash Goel |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma,
Ayurvedic and Unani Tibbia College and Hospital,
Ajmal Khan Road, Karol Bagh, Delhi – 110005
Central
DELHI
110005
India |
| Phone |
7982617449 |
| Fax |
|
| Email |
goelakash500@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma Ayurvedic and unani Tibbia College and hospital karol bagh new delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma,
Ayurvedic and Unani Tibbia College and Hospital,
Ajmal Khan Road, Karol Bagh, Delhi – 110005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Goel |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Panchakarma, OPD No. 2,
Ayurvedic and Unani Tibbia College and Hospital,
Ajmal Khan Road, Karol Bagh, Delhi – 110005
Central
DELHI |
7982617449
goelakash500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sushrat Samhita Chitiksthan 20/5, Procedure details: Shiro-Virechana Nasya Karma:
After evacuation of natural urges & routine hygiene, patient is placed in supine position. Mild Abhyanga over scalp, face & neck is done with Til Taila followed by Mridu Swedana. Lukewarm Karpasasthyadi Taila is instilled into both nostrils alternately (4–8 bindu per nostril) with head lowered at approximately 45°. Patient avoids speaking, sneezing or swallowing during administration. Post-procedure massage of head, neck, shoulders & feet is done, & excess medicine is expelled. Nasya is performed once daily for 14 days.
Salavaṇa Upanaha Swedana (Group A):
Lukewarm paste prepared from Salavaṇa, Vata-Kapha hara leaves (Nirgundi/Eranda) & Dhanyamla is applied over cervical region, covered with leaves & bandaged. Kept for 8–12 hours & removed, followed by local cleaning. Performed once daily for 14 days after Nasya.)
| | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sushrat Samhita Chitiksthan 20/5, Procedure details: Shiro-Virechana Nasya Karma:
After evacuation of natural urges & routine hygiene, mild Abhyanga over scalp, face & neck is done followed by Mridu Swedana. Patient is positioned supine with head lowered at approximately 45°. Lukewarm Karpasasthyadi Taila is instilled into both nostrils alternately (4–8 bindu per nostril). Post-procedure massage is done & excess medicine is expelled. Nasya is performed once daily for 14 days.
Jambira Pinda Swedana:
After Nasya, mild Abhyanga over cervical region is done with Mahanarayana Taila. Warm boluses prepared from Jambira, Saindhava Lavana, Haridra & Shatapushpa are applied over cervical spine using circular & kneading movements. Procedure is performed for 20–30 minutes once daily for 14 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 18-65 yrs of either gender.
2.Patients with any 2 or more Clinical features of cervical spondylosis, like:
a.Chronic or recurrent neck pain
b.Neck stiffness
c.Decreased Range of Motion
d.Headache
e.Radiating pain
3.Patients fit for Nasya Karma and localized Swedana karma over Neck region.
4.MRI evidence of degenerative changes in the cervical spine, including any of the following: Disc degeneration, Disc bulge or protrusion, Disc herniation.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are contraindicated for ShiroVirechana Nasya such as Pregnant women and lactating mothers, chronic rhinitis, etc.
2.Patients with renal or hepatic impairment (Sr. creatinine greater than 1.8 mgdl, SGOT and SGPT greater than THREE times of upper limit.
3.Patient having history of cervical instability, cord compression, central pain syndrome, cervical myelopathy, radiculopathy, compressive myelopathy, and muscle wasting,
4.Patients with comorbid conditions such as Hypertension (systolic greater than 160 mm Hg and diastolic greater than 100 mm Hg despite antihypertensive medications) and Diabetes Mellitus (having HbA1c greater than 7 percentage with or without oral hypoglycaemic medication).
5.Any medical red flag i.e. Spinal tumour, fracture, metabolic diseases, RA, spinal infection etc.
6.Patients requiring emergency treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome will be measured by proportion of patients showing improvement post-treatment assessed through ‘Neck Disability Questionnaire’. |
Baseline,day 15,day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome shall be measured though MRI of Cervical spine and assessed through Vas Score’ and ‘Range of Motion’ measured with Goniometer. |
Baseline,day 15,day 30 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical spondylosis is a common degenerative condition of the neck that causes neck pain, stiffness, restricted movements, and sometimes radiating pain to the arms. It commonly affects adults due to aging, poor posture, prolonged computer or mobile use, and sedentary lifestyle. Conventional treatment mainly provides symptomatic relief and may not be suitable for long-term use in all patients.
Ayurveda describes a similar condition as Manyastambha, which is managed using therapies like Nasya (nasal administration of medicated oil) and local fomentation procedures. Nasya is considered an important therapy for diseases of the head and neck, while external heat therapies help in reducing pain, stiffness, and improving mobility.
The purpose of this study is to compare the effectiveness of two Ayurvedic treatment approaches—Nasya therapy combined with Upanaha Swedana and Nasya therapy combined with Jambira Pinda Swedana—in reducing neck pain, improving neck function, and decreasing disability in patients with cervical spondylosis. |