| CTRI Number |
CTRI/2023/11/060321 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
VATHAROGA CHOORANAM for Cervical Spondylosis |
|
Scientific Title of Study
|
PHASE II NON RANDOMIZED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE VATHAROGA CHOORANAM FOR THE MANAGEMENT OF SAGANAVATHAM (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 |
Sathya Nandini T |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College,Chennai |
| Address |
Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College Arumbakkam, Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
8610042435 |
| Fax |
|
| Email |
sathyanandini14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chitra U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Post Graduate Department of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam ,Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sathya Nandini T |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College Arumbakkam, Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
8610042435 |
| Fax |
|
| Email |
sathyanandini14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam, Chennai |
|
|
Primary Sponsor
|
| Name |
Sathya Nandini T |
| Address |
Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai. |
| 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 |
| Sathya Nandini T |
Government Siddha Medical College, Chennai |
Room No.S1, Department of PG Pothu Maruthuvam, Arumbakkam, Chennai. Chennai TAMIL NADU |
8610042435
sathyanandini14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Government Siddha Medical College,Chennai. |
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 |
VATHAROGA CHOORANAM |
The Siddha drug will be given as 1500mg BD dose with Honey,for 48 days for the management of Cervical Spondylosis. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain radiating to upper limb with or without numbness,giddiness and neck stiffness.
Shoulder abduction pain relief sign -positive
Lhermittes and spurlings sign - positive |
|
| ExclusionCriteria |
| Details |
Known case of
Ankylosing spondylitis
Adhesive capsulitis
Traumatic injury
Extra cervical rib
Congenital spinal anomalies
Tuberculosis of spine
Secondary malignancy
Ischemic heart disease
Type II Diabetes Mellitus
chronic kidney disease
Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in clincal symptoms such as neck pain radiating to upper limb,numbness,neck stiffness. |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOGUE SCALE |
7 WEEKS |
|
|
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)
|
10/12/2023 |
| 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="0" Months="6" 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
|
Cervical spondylosis is the result of osteoarthritis in the cervical spine. It is characterised
by degeneration of the intervertebral discs and osteophyte formation. Such ‘wear and tear’ is
extremely common and radiological changes are frequently found in asymptomatic individuals
over the age of 50. Spondylosis may be associated with neurological dysfunction. .Osteoarthritis of the cervical spine may produce neck pain that radiates into the back of the head, shoulders, or arms, or may be the source of headaches in the posterior occipital region (supplied by the C2-C4 nerve roots).As the disks dehydrate and shrink, signs of osteoarthritis develop including bony projections along the edges of the bone. Cervical spondylosis is very common and worsens with age. More than 85 percent of people older than age 60 are affected by cervical spondylosis. The point prevalence of neck pain ranges from 0.4% to 41.5%, the 1-year incidence rangesfrom 4.8 to 79.5%[.The incidence of neck pain in adults in India is 25-50% per year. About 10million persons per year affected in India alone. In Siddha system of Medicine, there are unique combination of medicines which have the
solution to the SAGANAVATHAM (CERVICAL SPONDYLOSIS). One such combination is
VATHAROGA CHOORANAM which will be cost effective and reliable. As the literary evidences support the usage of medicine in the disease, a hypothesis
created in such a way that the efficacy of the VATHAROGA CHOORANAM will be a better
solution for SAGANAVATHAM (CERVICAL SPONDYLOSIS) and so permission may be given. |