| CTRI Number |
CTRI/2024/08/073155 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the effect of mahanarayana taila in cervical spondylosis |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evaluate the Effect of Mahanarayana Taila Marsha Nasya 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 |
Dr Sreeshma Gangadharan |
| Designation |
2nd year pg scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazretpet |
| Address |
Department of Panchakarma
Sri Jayendra Saraswathi Ayurveda College and Hospital, 4/295, CHENNAI BANGALORE HIGHROAD, NAZARATHPET, CHENNAI -600123, TAMIL NADU
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7306445547 |
| Fax |
|
| Email |
sreeshmaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chittaranjan Das |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazretpet |
| Address |
Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, 4/295, CHENNAI BANGALORE HIGHROAD, NAZARATHPET, CHENNAI -600123, TAMIL NADU
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123506 |
| Fax |
|
| Email |
drcrdayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeshma Gangadharan |
| Designation |
2nd yr pg scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazretpet |
| Address |
Department of Panchakarma,
Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, CHENNAI BANGALORE HIGHROAD, NAZARATHPET, CHENNAI -600123,TAMIL NADU
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7306445547 |
| Fax |
|
| Email |
sreeshmaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu 600123 |
|
|
Primary Sponsor
|
| Name |
Dr Sreeshma Gangadharan |
| Address |
Pg scholar
Department of panchakarma,
Sri Jayendra Saraswathi Ayurveda College and Hospital, 4/295, CHENNAI BANGALORE HIGHROAD, NAZARATHPET, CHENNAI -600123, TAMIL NADU |
| Type of Sponsor |
Other [Self] |
|
|
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 Sreeshma Gangadharan |
Sri jayendra Saraswati Ayurveda College and Hospital |
Department of panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, 4/295, CHENNAI BANGALORE HIGHROAD, NAZARATHPET, CHENNAI -600123, TAMIL NADU
Thiruvallur
TAMIL NADU |
07306445547
sreeshmaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Sri jayendra Saraswati Ayurveda college and Hospital deptof Ayurveda of SCSVMV |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 04(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karpasasthyadhi Taila, Reference: Sahasrayoga, Route: Nasal, Dosage Form: Taila, Dose: 04(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are complaining of stiffness and pain over the neck region.
Patients who are diagnosed as suffering from Cervical Spondylosis from X- ray report.
|
|
| ExclusionCriteria |
| Details |
Spinal abnormalities such as traumatic injuries, inflammatory conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the signs and symptoms of Cervical spondylosis using neck disability index scale and improvement of range of movements of cervical spine using goniometer at 7th day |
Patients will be assessed after 7 days of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - google scholar
- For how long will this data be available start date provided 26-08-2024 and end date provided 18-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cervical Spondylosis is the Disc degeneration with associated osteophyte formation and osteoarthritis of the spinal apophyseal joints with clinical manifestations like restricted movements of neck along with pain and stiffness while doing work. Manyastambha is a Vata Nanatmaja Roga which occurs due to Avarana of Vata by Kapha through the repetitive indulgence in the Nidana. The Lakshanas of Manyastambha include Stambha or Nischaleekarana of the Nadis present at the Manya pradesha along with Shoola. Nasya is the instillation of medicines through the nasal route and is indicated for all Urdhwa Jatrugata Vikaras. Bruhmana Nasya has the potential to strengthen the Greeva and skandha thereby acting on Manystambha. So an attempt is made to compare the effect of Mahanarayana Taila Marsha Nasya in the management of Cervical Spondylosis. |