| CTRI Number |
CTRI/2025/07/091880 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ashwagandhadi Taila Nasya In Manyasthambha . |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Ashwagandhadi Taila And Moorchita Tila Taila Nasya In The Management Of Manyasthambha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mishra Kumari Kirti Lalbabu |
| Designation |
Post Graduation (Panchakarma) |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College And Hospital, Panchakarma Department Vidyagiri,Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8451877116 |
| Fax |
|
| Email |
mishrakirti207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikram Kumar |
| Designation |
Professor (Panchakarma) |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College And Hospital, Panchakarma Department Vidyagiri,Moodubidire
Alvas Ayurveda Medical College And Hospital, Panchakarma Department Vidyagiri,Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8451877116 |
| Fax |
|
| Email |
Vikramkumar83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mishra Kumari Kirti Lalbabu |
| Designation |
Post Graduation (Panchakarma) |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College And Hospital, Panchakarma Department Vidyagiri,Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8451877116 |
| Fax |
|
| Email |
mishrakirti207@gmail.com |
|
|
Source of Monetary or Material Support
|
| alvas ayurveda medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Mishra Kumari Kirti Lalbabu |
| Address |
Alvas Ayurveda Medical Collage And Hospital |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mishra Kumari Kirti Lalbabu |
Alvas ayurveda medical college |
Panchakarma Department Vidyagiri,Moodubidire
Dakshina Kannada
KARNATAKA |
08451877116
mishrakirti207@gmail.com |
| Mishra Kumari Kirti Lalbabu |
Alvas ayurveda medical college |
Panchakarma Department Vidyagiri,Moodubidire
Dakshina Kannada
KARNATAKA |
08451877116
mishrakirti207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommittee, alvas Ayurveda Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi Taila |
Ashwagandhadi taila has been told in tailadhikara vata vyadhi chikitsa in Gadhanigrah.it isadministered as nasya 4ml in each nostril for 7days |
| Comparator Agent |
Moorchita til Taila |
it has told best among all taila. it is administered as nasya ,4ml in each nostril for 7days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pt Having Classical Symptoms of Manyasthambha.
Pt Who are Fit For Nasya Karma. |
|
| ExclusionCriteria |
| Details |
congenital condition of cervical spine.
Patients with traumatic injuries to spine, infection of bone and gross bony deformity other cervical spine pathology. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Ashwagandhadi Taila Nasya over Pain and stiffness |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in pain during followup |
14days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/08/2025 |
| 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="4"
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
|
This is randomized comparative clinical study to evaluate the efficacy of Ashwagandhadi Taila and Moorchit Tila Taila Nasya in Management of Manyasthambha. Here patient selected with age group between 20-60 yr, irrespective of socio-economic status and class with diagnostic criteria as Neck Pain and Neck Stiffness. 40 Patient Selected having 20 Patient in each group will be treated with Nasya Karma for 7days and Follow Up will be done on 15th day. sample source are from OPD and IPD of Panchakarma Department in Alvas Ayurveda Medical College and Hospital, camp and other refferrals. |