| CTRI Number |
CTRI/2020/12/029521 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [Thokkkanam external theraphy] |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical study on Thandaga vatham (Lumbar Spondylosis) with thokkanam (pidithal murai, External theraphy) Ilagu vida mutti thylam (external medicine) and pirappan kizhangu chooranam (internal medicine) |
|
Scientific Title of Study
|
An open labelled double arm non randomized phase-II clinical trial to evaluate the therapeutic efficacy of PIRANPAN KIZHANGU CHOORNAM (INTERNAL) ILAGU VIDA MUTTI THYLAM (EXTERNAL) AND THOKKANAM (PIDITHAL MURAI EXTERNAL THERAPY) in the management of THANDAGA VATHAM (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 |
P Jeyapaul |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital Palayamkottai |
| Address |
Department of pura maruthuvam,OP NO 4 Government siddha medical college and hospital Palayamkottai
Tirunelveli
Tamil nadu
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9488856423 |
| Fax |
|
| Email |
jeyapaulsteve@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ahamed mohideen |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college and hospital Palayamkottai |
| Address |
Department of pura maruthuvam Government siddha medical college and hospital Palayamkottai
Tirunelveli
Tamil nadu
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442542282 |
| Fax |
|
| Email |
dr.ahmed63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ahamed mohideen |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college and hospital Palayamkottai |
| Address |
Department of pura maruthuvam Government siddha medical college and hospital Palayamkottai
Tirunelveli
Tamil nadu
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442542282 |
| Fax |
|
| Email |
dr.ahmed63@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NUMBER-4 GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital palayamkottai
|
| Type of Sponsor |
Other [Government 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 |
| P Jeyapaul |
Government siddha medical college and hospital |
op no4, department of pura maruthuvam,Government siddha medical college palayamkottai
Tirunelveli
Tamil nadu
Tirunelveli
TAMIL NADU |
9488856423
jeyapaulsteve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt siddha medical college and hospital |
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 |
Thokkanam(Pidithal murai) external therapy |
Thokkanam(Pidithal murai) external therapy 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 lower limbs, stiffness present in lumbar region, Exacerbation of pain on movements, Pain increased on forward bending, Tingling sensation.(Numbness)
Patients who are willing to give radiological investigation and provide blood for lab investigation.
Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
Cardiac disease
Auto immune diseases like Rheumatoid arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
Spina bifida
Osteo myelitis
Renal Disease
Tuberculosis in spine
Patient with any other serious illness
Other systemic illness
Dislocation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Thokkanam External therapy) and Group II (Medicine and Thokkanam External therapy)
Comparison of efficacy in patient Group I and Group II |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of quality of life by universal pain score scale
Assessment of safety parameters |
48 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)
|
15/12/2020 |
| Date of Study Completion (India) |
25/05/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
Lumbar spondylosis is a degenerative changes in disc and lumbar spine. Disc degeneration is age related and starts in the 3rd decade. Reduction in the molecular size of the proteoglycans of the Nucleus Pulposus is associated with loss of viscol elastic properties, increased load bearing by the annulus is followed by focal damage and disc herniation in some cases. Disc prolapse and osteophytosis can formed root compression and indirect ischemic neuronal damage.
Thokkanam signifies a group of therapeutic procedures, usually done with hand on the body in nine different ways, with or without the application of medicated oil (Thailam). These procedures can either be curative or palliative. Normally Thokkanam is done for diseases in which Vaatham is the mostly deranged. |