| CTRI Number |
CTRI/2021/01/030464 [Registered on: 14/01/2021] Trial Registered Prospectively |
| Last Modified On: |
12/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [Yoga] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yoga for thandagavatham ( lumbar spondylosis) |
|
Scientific Title of Study
|
AN OPEN CLINICAL TRIAL OF YOGASANAM IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRRajpriya R |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
Chennai
TAMIL NADU
600047
India |
| Phone |
6374417390 |
| Fax |
|
| Email |
drrajimani1004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVMahalakshmi |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
Chennai
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVMahalakshmi |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
ROOM NO 3A ,Department of Siddhar yoga maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai 600047
India
Chennai
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
Ayothidoss pandithar hospital,National institute of Siddha Tambaram sanatorium, 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 |
| Rajpriya R |
Ayothidoss pandithar hospital |
Room 3A Department of Siddhar Yoga Maruthuvam,Tambaram sanatorium, chennai,tamil nadu.
Chennai
TAMIL NADU |
6374417390
drrajimani1004@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: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
YOGAM |
Frequency - Daily once(early morning) for 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of pain in the lumbar region.
Radiating pain to buttocks and lowers limb
Stiffness present in lumbar region.
Pain increased on forward bending.
Tingling sensation.(Numbness present in lower limbs).
|
|
| ExclusionCriteria |
| Details |
Recent history of trauma, fracture , surgery
H/o Cardiac diseases
H/o Diabetes mellitus
H/o Uncontrolled hypercholesterolemia
H/o Uncontrolled Hypertension
H/o Rheumatoid arthritis
H/o Chronic kidney disease
Pregnancy and lactation
Tuberculosis in spine
Sexually transmitted diseases
Osteomyelitis
Ankylosing spondylitis
Spinal deformity
Pyogenic bone infection
Bowel and bladder incontinence
Patient with any other serious systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| universal pain assessment scale |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the siddha basic principles relevant to the diseases |
48 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
19/01/2021 |
| 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="1"
Months="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is the single arm study to evaluate the efficacy of yogasanam in the management of thandagavatham in 40 patients for 48 days. |