| CTRI Number |
CTRI/2025/05/086135 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"An Open labelled non randomised phase II clinical trial to evaluate the effectiveness of SAGALAVAYU OTTRADAM(external therapy)in the management of Cervical spondylosis" |
|
Scientific Title of Study
|
"An Open labelled non randomised phase II clinical trial to evaluate the effectiveness of SAGALAVAYU OTTRADAM(external therapy)in the management of CEGANA VATHAM(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 |
APushpalatha |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Second year
Department of puramaruthuvam
Government siddha medical College and hospital
Palaymkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010050895 |
| Fax |
|
| Email |
pushpalathaamirthalingam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S SUJATHA MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital palaymkottai |
| Address |
Department of puramaruthuvam
Government siddha medical college and hospital
Palaymkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010050895 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S SUJATHA MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital palaymkottai |
| Address |
Department of puramaruthuvam
Government siddha medical college and hospital
Palaymkottai
TAMIL NADU
627002
India |
| Phone |
7010050895 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of government siddha medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Dr A PUSHPALATHA |
| Address |
Second year pg scholar department of puramaruthuvam government siddha medical College and hospital palaymkottai tirunelveli |
| 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 A PUSHPALATHA |
Government siddha medical College and hospital |
Pg department of puramaruthuvam government siddha medical College and hospital palaymkottai tirunelveli
Tirunelveli
TAMIL NADU |
7010050895
pushpalathaamirthalingam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethical committee government siddha medical College and hospital palaymkottai tirunelveli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SAGALAVAYU OTTRADAM |
A duration of 20 -30 minutes for 7 days repeat with 2 such course with an interval of 5 days in between each course |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pain present in the neck region radiating to the back of head, top of shoulder, shoulder blades, upper limbs.with or without numbness in the upper limbs, giddiness and neck stiffness,patient who are willing for admission and stay in IPD or willing to attend OPD.partciants with mild and moderate symptoms. |
|
| ExclusionCriteria |
| Details |
Recent history of Trauma and fracture, dislocation of cervical vertebra and surgery
cord compression
Tuberculosis in spine & pyogenic bone infection
Spondylolisthesis and ankylosing spondylitis
Auto immune diseases like RA, SLE, psoriatic arthritis and mixed connective tissue disorders
Tuberculous arthritis
Cervical myelopathy
Cervical rib
Torticollis (wry neck)
Osteochondritis Tumour in vertebral body
Meningitis
Participants who need internal medicine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to understand the effectiveness of external therapy SAGALAVAYU OTTRADAM towards the management of CEGANA VATHAM (CERVICAL SPONDYLOSIS). Prognosis of CEGANA VATHAM and improvement in the patients quality of life will be assessed and documented. |
31 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
This study is an open labelled non-randomized phase II clinical trial to evaluate the efficacy of
SAGALAVAYU OTTRADAM an external therapy in the management of CEGANA VATHAM( CERVICAL SPONDYLOSIS )The trial drug will be
an external application for 29- 30 minutes for 7 days repeat with 2 such course with an interval of 5 days in between each course for 40 patients.The trial period of 24 months will be
carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002,
Tamilnadu.The outcome will be an external therapy in SAGALAVAYU OTTRADAM towards the management of
CEGANA VATHAM (CERVICAL SPONDYLOSIS) and expect the patients to be relieved from the symptom.In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further
management of patients will be given OPD patients. |