| CTRI Number |
CTRI/2020/07/026694 [Registered on: 20/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [SIDDHAR YOGAM THERAPY] |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical study on Chukku Karpam for cegana vatham (Cervical spondylosis) |
|
Scientific Title of Study
|
A Open labelled double arm non randomized phase II clinical trial, to evaluate the therapeutic efficacy of siddhar yogam therapy and siddha kalpa medicine Chukku Karpam (Internal) in the management of cegana vatham (Cervical spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V TAMILSELVI |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM OP NO 4 GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM OP NO 4 GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9487930423 |
| Fax |
|
| Email |
tamilselvibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Poongodi Kanthimathi |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S Poongodi Kanthimathi |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
OP NO 4 DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 627002 |
| Type of Sponsor |
Other [Govt Siddha Medical college and Hospital] |
|
|
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 |
| V TAMILSELVI |
Government Siddha Medical College Hospital Tirunelveli |
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM GOVERNMENTT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
Tirunelveli
TAMIL NADU |
9487930423
tamilselvibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt Siddha Medical College Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Siddhar yogam therapy |
Siddhar yogam therapy for 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain
Radiating pain towards upper limbs
with or without numbness in the upper limbs
giddiness and neck stiffness
Patients who are willing to give blood samples for laboratory investigation
Patients who are willling to take x ray before and after treatment
willing for admission in IPD for 30 days or willing to OPD regularly
Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent |
|
| ExclusionCriteria |
| Details |
Cardiac Disease
Benign and malignant Neoplasm
spina bifida
ankylosing spondylosis
Congenital anomalies of spine
Severe Osteoporosis of cervical spine
Cervical rib
pregnant women and lactating mother
Trauma
Syringomyelia
Tuberculosis in spine
Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of change from baseline in Universal Pain Assessment scale at day 30 between GROUP I and GROUP II |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of the drug
To review the pharmacological activity
to develop the knowledge about siddha kalpa medicine and yogam therapy
to prove the efficacy of siddhar yogam therapy for cegana vatham |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/07/2020 |
| Date of Study Completion (India) |
03/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
cervical spondylosis is a common degenerative condition of the cervical spine. it is most likely caused by age related changes in the intervertebral discs. in cervical spine, some degree of degenerative change is a normal radiological findings in the middle aged and elderly. Degenaration of the intervertebral discs and secondary osteoarthrosis (cervical spondylosis) is often asymptomatic but may be associated with neurological dysfunction. The C4/5, C5/6, C6/7 vertberae are most commonly affected Siddhar Yogam therapy is a therapy for the combination of physical and mental excercises |