| CTRI Number |
CTRI/2023/02/049642 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ON THALISATHY CHOORANAM (INTERNAL) AND LAGUVISHAMUTTI THYLAM
(EXTERNAL) IN THE MANAGEMENT OF SAGANAVATHAM (CERVICAL
SPONDYLOSIS) |
|
Scientific Title of Study
|
AN OPEN CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF
“THALISATHY CHOORANAM (INTERNAL) AND LAGUVISHAMUTTI THYLAM
(EXTERNAL) IN THE MANAGEMENT OF SAGANAVATHAM (CERVICAL
SPONDYLOSIS) AMONG THE PATIENTS ATTENDING AYOTHIDOSS PANDITHAR
HOSPITAL,NATIONAL INSTITUTE OF SIDDHA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Dhanakumari |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9524825994 |
| Fax |
|
| Email |
dhanakumari1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Dhanakumari |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9524825994 |
| Fax |
|
| Email |
dhanakumari1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha
Tambaram Sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai |
| Type of Sponsor |
Research institution 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 |
| Dr P Dhanakumari |
Ayothidoss Pandithar Hospital |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU |
9524825994
dhanakumari1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
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 |
Thalisathy chooranam (internal)
Laguvishamutti thylam (extrenal) |
Internal 2gms bd with milk
External oil 10ml application
For 48 days |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck pain radiating to back of head,top of shoulders,shoulder blades,upper arms and hands
2. Neck stiffness and restricted movements of neck.
3. Numbness and paresthesia of neck or shoulders or upper limbs
4. The Neck Disability Index score should be equal or greater than 40%
5. Patient who are willing to sign informed consent form.
6. Patients who are willing to give radiological investigation.
|
|
| ExclusionCriteria |
| Details |
1. Traumatic injury
2. Ischemic heart diseases
3.Chronic Kidney disease
4. Tuberculosis in spine
5. Congenital spinal anomalies
6. Pregnant women and lactating mothers.
7. Cervical Rib
8. Ankylosing spondylitis
9.Adhesive capsulitis
10.Diabetes mellitus (uncontrolled) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The therapeutic efficacy of trial drug is assessed through improvement in neck disability index score and Visual pain analog scale before and
after treatment |
2 MONTHS- SCREENING
2 MONTHS- DATA COLLECTION
2 MONTHS- DATA ANALYSIS AND OUTCOME |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
14/02/2023 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: This is an open clinical trail that evaluates the effectiveness of siddha formulation THALISATHY CHOORANAM(INTERNAL) AND LAGUVISHAMUTTI THYLAM (EXTERNAL) in the management of SAGANAVATHAM(CERVICAL SPONDYLOSIS) patients through improvements in the neck disability index score and visual pain analog sacle before and after treatment. Cervical spondylosis is the result of osteoarthritis in the cervical spine. It is characterised by degeneration of the intervertebral discs and osteophyte formation. 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, and produces neck stiffness sometimes numbness or paresthesia of upper limbs. Spondylosis may be associated with neurological dysfunction. In order of frequency, the C5/6, C6/7 and C4/5 vertebral levels affect C6, C7 and C5 roots, respectively. OUTCOME: Improvement in neck disability index and Visual pain analog scale before and after treatment MATERIALS AND METHODS: A total of 10 diagnosed adult patients of SAGANAVATAHM(CERVICAL SPONDYLOSIS) willing to participate in the study , by signing the consent form will be enrolled in the study.Having neck pain radiating to back of head,top of shoulders,shoulder blades,upper arms and hands,neck stiffness and restricted movements of neck , numbness and paresthesia of neck or shoulders or upper limbs , the Neck Disability Index score should be equal or greater than 40%, patients who are willing to give radiological investigation will be included and K/H/O Traumatic injury,congenital spinal abnormalities,tuberculosis of spine ,cervical rib,adhesive capsulitis,ankylosing spondylitis,other ischemic heart disease,or renal disease , uncontrolled diabetes mellitus and pregnancy,lactation will be excluded.Assessment is done through neck disability index score and visual pain analog scale before and after treatment. RESULTS AND DISCUSSION: The result will be statistically analyzed KEYWORDS: Thalisathy chooranam,Saganavatham,Cervical spondylosis |