| CTRI Number |
CTRI/2023/09/057668 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare The Effect Of Tila Taila and Karpasasthyadi Taila As a Nasya Karma In The Management of Manyastambha (Cervical Spondylosis) |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Evaluate The Effect Of Tila Taila Nasya In The Management Of Manyastambha (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 Biplab Keshari Jena |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room No 20 Second Floor Department of Panchakarma Sri
Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet
Chennai
Thiruvallur
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9438742067 |
| Fax |
|
| Email |
jena.biplabkeshari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen BS |
| Designation |
Vice Principal & Professor, Department of Panchakarma |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room No 20 Second Floor Department of Panchakarma Sri
Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet
Chennai
Thiruvallur
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9964006795 |
| Fax |
|
| Email |
praveenbs76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshma Ramakrishnan |
| Designation |
Assistant Professor, Department of Panchakarma |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room No 20 Second Floor Department of Panchakarma Sri
Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet
Chennai
Thiruvallur
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9656678916 |
| Fax |
|
| Email |
reshmaramakrishnan007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123 Department of
Panchakarma Room No 20 Second Floor |
|
|
Primary Sponsor
|
| Name |
Dr Biplab Keshari Jena |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai
600123 Department of Panchakarma Room No 20 Second Floor |
| 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 Biplab Keshari Jena |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room No 20 Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Thiruvallur
TAMIL NADU |
9438742067
jena.biplabkeshari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital, Department of Ayurveda, SCSVMV, Nazarathpet, Chennai 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: MANYASTAMBAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Susruta Samhita, Procedure details: Patient will be made to lie down in supine position in order to facilitate easy administration of nasya drugs through nose. The medicine is warmed by placing it in a hot water & then poured into gokarna. Uninterruptedly 4ml of warmed taila will be instilled in each nostril alternatively. Mild massage of the scalp, forehead, ears, neck palms and soles will be done. The patient is asked to inhale the medicine with moderate force. The medicine when reaches the mouth advice patient to turn both the)
(1) Medicine Name: Karpasasthyadi Taila, Reference: Sahasrayogam , Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Susruta Samhita, Procedure details: Patient will be made to lie down in supine position in order to facilitate easy administration of nasya drugs through nose. The medicine is warmed by placing it in a hot water & then poured into gokarna. Uninterruptedly 4ml of warmed taila will be instilled in each nostril alternatively. Mild massage of the scalp, forehead, ears, neck palms and soles will be done. The patient is asked to inhale the medicine with moderate force. The medicine when reaches the mouth advice patient to turn both the)
(1) Medicine Name: Tila Taila, Reference: Bhavaprakasa, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fit for Nasya Karma.
Patients having sign and symptoms of Manyastambha (Cervical Spondylosis) |
|
| ExclusionCriteria |
| Details |
Patients with injury to cervical spine and spinal surgery.
Patients diagnosed with infection and neoplastic condition of spine.
Patient unfit for Nasya Karma. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the sign and symptoms of Manyastambha (Cervical Spondylosis) by using NECK DISABILITY INDEX Scale & Improve Range of movements of Cervical Spine- using a goniometer. |
Patients from both the groups will be assessed after 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/09/2023 |
| 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 - NO
|
|
Brief Summary
|
Nasya Karma is a therapeutic procedure in which the drug is administered through nose,
eliminates or pacifies the vitiated doshas accumulated in the head and is beneficial in diseases
of Urdwajatrugata vikara . Nasya Karma strengthens the snayu and kandara of Greeva .
Manyastambha is mentioned among eighty Nanatmaja vata vyadhi. It is characterized by
Stiffness or Rigidity in the back of neck and the movements of neck are impaired. Cervical
Spondylosis can be co-related with Manyasthambha in ayurvedic prospective. In India 25-50%
of adults are suffering from cervical spondylosis every year. 75% of people are more prone to
suffer from cervical spondylosis over the age of 50 years. On an average 69% of male and 31%
of female suffer from Cervical spondylosis. Acharya susruta has mentioned that the aggravated
vayu, if it located in the shoulders, the chest, the Trik or the Manya should be managed with
Vamana and Nasya karma. Nasya karma being the treatment of choice in Urdhwajatrugata
Vyadhis can be best adopted in the management of Manyastambha. Bhavaprakasa in Taila
varga adhyaya has mentioned Tila Taila can be administered in the form of Nasya Karma. Tila
Taila consists of drugs which are Guru guna, Balya and Vatakaphapaham in nature, useful in
the treatment of manyastambha. Clinical Study on Nasya karma with Karpasasthyadi Taila in
cervical spondylosis has been done earlier with statistically high significant results in neck pain
and stiffness. Ingredients of Tila Taila are easily available and cost effective when compared
to Karpasasthyadi Taila. In this present study, Karpasasthyadi Taila is taken as Nasya Karma
for the control group. Therefore, an attempt is made to compare the therapeutic effect of Nasya
karma with Tila Taila and Karpasasyathi Taila in the management of Manyastambha. |