| CTRI Number |
CTRI/2019/06/019586 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varma Manipulation] |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial on Koarai vatham |
|
Scientific Title of Study
|
An Open labelled double arm non-randomised phase II clinical trial to compare the efficacy of VARMA MANIPULATION with KARUNKURINJI KUDINEER (INTERNAL)and ETTI PATTAI ENNAI (EXTERNAL) in the treatment of KOARAI VATHAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAVITHA |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
| Address |
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9445816706 |
| Fax |
|
| Email |
ezhilmano93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S SUJATHA |
| Designation |
LECTURER |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
| Address |
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
rajasekarsujatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S SUJATHA |
| Designation |
LECTURER |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
| Address |
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
rajasekarsujatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
|
|
Primary Sponsor
|
| Name |
KAVITHA |
| Address |
DEPARTMENT OF VARMA MARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Type of Sponsor |
Government medical college |
|
|
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 |
| S Kavitha |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
PG DEPARTMENT OF VARMA MARUTHUVAM OP NO 4
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI
Tirunelveli
TAMIL NADU |
9445816706
ezhilmano93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt Siddha Medical College Palayamkottai |
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 |
varma manipulation for 48 days intermittently With internal medicine and external oil |
Varma manipulation intermittently for 48 days
With
karunkurinji kudineer internal
Dose-90ml bd(before food)
Duration-12days
Etti pattai ennai external application
Dose-30ml
Duration-48 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 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 |
Auto immune diseases like Rheumatoid arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
Spina bifida
Pregnancy and lactation
Osteo myelitis
Renal Disease
Tuberculosis in spine
Patient with any other serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of change from baseline in QUEBEC BACK PAIN DISABILITY SCALE at day of between Group I and Group II for varma manipulation and internal and external medicine |
Group I Intermittent varma manipulation within 48 days
1st sitting 50 percentage of symptoms will reduce
2nd sitting 80 percentage of symptoms will reduce
Group II After giving internal and external medine for 12 days with varma manipulation 50 percentage of primary symptoms will reduce
within 48 days 80 percentage of symptoms will reduce |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of OSWESTRY LOWBACK PAIN DISABILITY QUESTIONNAIRE.
Assessment of safety parameters |
Group I Intermittent varma manipulation within 48 days
1st sitting 50 percentage of symptoms will reduce
2nd sitting 80 percentage of symptoms will reduce
Group II After giving internal and external medine for 12 days with varma manipulation 50 percentage of primary symptoms will reduce
within 48 days 80 percentage of symptoms will reduce |
|
|
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)
Modification(s)
|
20/06/2019 |
| Date of Study Completion (India) |
06/04/2020 |
| 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
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
LUMBAR SPONDYLOSIS is the term given to the
occurrence of degenerative disc disease and osteoarthritic change in the lumbar
spine. Within the literature, lumbar spondylosis encompasses numerous associated pathologies
including spinal stenosis, degenerative spondylolisthesis, osteoarthritis and
many others.spondylosis is not aclinical diagnosis but instead a descriptive
term utilized to designate spinal problems.
The
lumbar spine carries most of the body’s weight. therefore degenerative changes
affect its structure causes pain with activity such as walking and standing
,lifting objects or after a long period of rest. The manipulation of varma points
for treating diseases is called varma therapy.
According to varma text
the signs and symptoms of koarai vatham mentioned in vatha noi nithanam
can be correlated with lumbar
spondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800).
This study is to evaluate the therapeutic efficacy of Varma
Manipulation and clinical efficacy of
karunkurinji kudineer (Internal) and ulunthennai (External).on koarai
vatham (lumbar spondylosis).
The manipulation of varma points
for treating diseases is called varma therapy.
According to varma text
the signs and symptoms of koarai vatham mentioned in vatha noi nithanam
can be correlated with lumbar
spondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800).
This study is to evaluate the therapeutic efficacy of Varma
Manipulation and clinical efficacy of
karunkurinji kudineer (Internal) and ulunthennai (External).on koarai
vatham (lumbar spondylosis).
|