| CTRI Number |
CTRI/2022/05/042790 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open labelled clinical study to evaluate the therapeutic efficacy of THOKKANAM( IZHUTHAL MURAI) – An external therapy using VATHA NOIKKU ENNAI (EXTERNAL) in the management of CERVICAL SPONDYLOSIS |
|
Scientific Title of Study
|
"An open labelled clinical study to evaluate the therapeutic efficacy of THOKKANAM( IZHUTHAL MURAI) – An external therapy using VATHA NOIKKU ENNAI (EXTERNAL) 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 |
Dr G MOHANA KRISHNAN |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI |
| Address |
II YEAR PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
II YEAR PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9677629532 |
| Fax |
|
| Email |
dr.krishnan007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G GANESAN |
| Designation |
LECTURER II |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI |
| Address |
DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G GANESAN |
| Designation |
LECTURER II |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI |
| Address |
DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
DEPARTMENT OF PURA MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI, TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Govt Siddha Medical College and Hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr G MOHANA KRISHNAN |
| Address |
II YEAR PG SCHOLAR,DEPARTMENT OF PURA MARUTHUVAM,GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI,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 G MOHANA KRISHNAN |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
II YEAR PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM,GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALYAMKOTTAI,TIRUNELVELI
Tirunelveli
TAMIL NADU |
9677629532
dr.krishnan007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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 |
THOKKANAM-IZHUTHAL MURAI (EXTERNAL THERAPY)
VATHA NOIKKU ENNAI(EXTERNAL MEDICINE) |
15-20 Minutes/ once a day for one week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age Between 20 and 65 years
sex Both male and female
Neck pain
Radiating pain to the upper limbs
With or without numbness in the upper limb
Giddiness and neck stiffness
Patient who are willing for admission and stay in IPD or willing to attend OPD
Patient who are willing to give blood samples for laboratory investigations
|
|
| ExclusionCriteria |
| Details |
cervical rib
trauma
spina bifida
ankylosing spondylosis
tuberculosis in spine
cardiac disease
hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the intensity of pain |
Decrease the intensity of pain with in 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
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)?
Response - NO
|
|
Brief Summary
|
It is an open labelled clinical study to evaluate the therapeutic efficacy of THOKKANAM( IZHUTHAL MURAI ) – An external therapy using VATHA NOIKKU ENNAI (EXTERNAL) in the management of CEGANA VATHAM (CERVICAL SPONDYLOSIS) |