| CTRI Number |
CTRI/2026/01/102516 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Procedure] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two treatments given through the nasal route using a medicated milk preparation for neck pain caused by cervical spondylosis. |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the effect of Nasya and Nasapana with Prasaranyadi ksheera kashaya in 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 |
SREESHMA P |
| Designation |
PG Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Second year PG Scholar, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, 682301, India
Ernakulam
KERALA
682301
India |
| Phone |
8943265815 |
| Fax |
|
| Email |
sreeshmawdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Remya Vijayan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, 682301, India
Ernakulam
KERALA
682301
India |
| Phone |
9847852619 |
| Fax |
|
| Email |
dr.remyavijayan83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Remya Vijayan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, 682301, India
Ernakulam
KERALA
682301
India |
| Phone |
9847852619 |
| Fax |
|
| Email |
dr.remyavijayan83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura, Ernakulam, Kerala- 682301 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura |
| Address |
Government Ayurveda College Tripunithura, Dhanwantari Nagar, Puthiyakavu, Ernakulam, Kerala- 682301 |
| Type of Sponsor |
Other [Government Ayurveda College Tripunithura] |
|
|
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 Remya Vijayan |
Government Ayurveda College and Hospital, Tripunithura |
Department of Panchakarma,Government Ayurveda College and Hospital, Puthiyakavu, Dhanwanthari Nagar,Tripunithura, Eranakulam, 682301
Ernakulam
KERALA |
9847852619
dr.remyavijayan83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College, Tripunithura, Kochi, Kerala- 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VISVACI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasapana | (Procedure Reference: Vangasena Vatavyadi Adhyaya, Procedure details: Nasapana with Prasaranyadi ksheera kashaya for 7 days with an increasing dose upto 20ml in each nostrils)
(1) Medicine Name: Prasaranyadi ksheera kashaya, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Ksheerpaka, Dose: 20(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hrdaya , Procedure details: Nasya with Prasaranyadi ksheera kashaya for 7 days with an increasing dose upto 10 bindu in each nostrils )
(1) Medicine Name: Prasaranyadi ksheera kashaya, Reference: Sahasrayoga, Route: Nasal, Dosage Form: Ksheerpaka, Dose: 5(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Duration of disease less than 10 years
Participants satisfying Neck disability index with mild to moderate disability
Diagnosed as cervical spondylosis based on sign and symptoms or radiological evidence
Participants fit for Nasya |
|
| ExclusionCriteria |
| Details |
Participants with history of cervical spine trauma, fracture, surgery
Diagnosed case of stroke, Cardiac disease, Autoimmune disease , Malignancy
Participants suffering from acute upper, lower respiratory infections, sinusitis, Obstructive nasal pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the pain and functional improvement by Neck Disability Index
To assess the range of movements of Cervical spine and Shoulder joint using Goniometry |
Treatment period-7 days
Assessment will be done on 0th, 8th, and 21st day with Neck Disability Index and range of movements of cervical spine and shoulder joint assessed by Goniometer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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 Applicable |
| 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
|
A comparative clinical trial with 38 participants 19 in each group will be selected from the IPD of Department of Panchakarma, Govt Ayurveda College, Tripunithura based on inclusion and exclusion criteria. The Neck Disability Index score and Range of Movements of cervical spine and shoulder joint will be assessed 0th day 8th day( after treatment) and 21st day. One group will be given Nasapana with Prasaranyadi ksheera kasaya for 7 days with an increasing dose upto 24 ml in each nostrils and another group will be given Nasya with Prasaranyadi ksheera kasaya for 7 days with an increasing dose upto 10 bindus in each nostrils. The outcome of the study will be assessed, processed and analyzed statistically. |