| CTRI Number |
CTRI/2020/07/026372 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Pavattai ilai kudineer in the management of Thandaga Vatham (Lumbar Spondylosis) |
|
Scientific Title of Study
|
A Prospective open labelled non randomized phase II clinical study on pavattai ilai kutinir in the management of Tantaka Vatam (lumbar spodylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Pazhanimurugan |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
II Year PG Scholar
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
627 002
India
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
7502511132 |
| Fax |
|
| Email |
drpalanichinna001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash chandran MD PhD |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
627 002
India
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Subash chandran MDs PhD |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
627 002
India
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of Government siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tamilnadu
627 002
India |
| 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 |
| G pazhanimurugan |
Government Siddha Medical College |
Department of Pothu Maruthuvam
Room No 10
Palayamkottai
Tirunelveli
Tamilnadu
627 002
India
Tirunelveli
TAMIL NADU |
7502511132
drpalanichinna001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Pavattai ilai Kudineer |
30 to 50 ml/Twice a day/ BF |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient presenting with pain and stiffness in the Lumbar region,radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
2)Schoper,SLR test positive in Thandaga Vatham.
3)Patient complaining of back pain functional scale score should be range from below 30.
4)Patient willing to participate the clinical trial.
5)Confirmed Radiological diagnosis in Lumbar Spondylosis |
|
| ExclusionCriteria |
| Details |
1)Tuberculosis of spine
2)SLE
3)Chronic kidney disease
4)Fracture of spine
5)Congenital Spino Vertebral Deformities
6)Mixed connective disease
7)Pregnency
8)Lactating mother
9)Chronic liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
If during treatment or after treatment reduction of the following symptoms
Pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward beding. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Documentation of analgesic activity through SCALE SCORE. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| Date of Study Completion (India) |
17/04/2021 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study is a prospective open labelled phase II non randomized clinical study to evaluvate the therapeutic efficacy of pavattai ilai kudineer in the management of Thandaga Vatham ( Lumbar Spondylosis). The trial drug will be administered at the dose of 30 to 50 ml/Twice a day B/F 45 days in 60 patients. The trial period of 12 months will be carrying out in Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamilnadu. The Primary outcome will be their evaluation of therapeutic efficacy of trial drug pavattai ilai kudineer. The Secondary outcome will be they evoluation of siddha diagnostic Parameters, assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse event (AE) is notice and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD facility. |