| CTRI Number |
CTRI/2021/02/031215 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| 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 of Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis) |
|
Scientific Title of Study
|
A prospective open labelled non randomized phase II clinical trial of Mavilingapattai Kudineer 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 |
Dr P Mullaikodi |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9080394757 |
| Fax |
|
| Email |
drmullaikodiparamasivam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Justus Antony MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Justus Antony MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and central library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Palayamkottai
Tirunelveli
Tamilnadu
627002 |
| 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 |
| Dr P Mullaikodi |
Government siddha medical college and hospital |
PG Department of Pothu Maruthuvam,
Op no.10,
Government siddha medical college and hospital, Palayamkottai.
Tirunelveli
TAMIL NADU |
9080394757
drmullaikodiparamasivam@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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mavilingapattai Kudineer |
30ml orally twice a day after food for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
Patient with positive Schober and Straight Leg Raising test.
Patient complaining of back pain functional scale score should be range from below 30. |
|
| ExclusionCriteria |
| Details |
Age below 30 and above 60 years.
Tuberculosis of spine.
Systemic Lupus Erythematosus
Chronic Kidney Disease
Fracture of spine
Congenital Spino vertebral deformities
Mixed connective disease
Pregnancy
Lactating mother
Chronic Liver Disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of the symptoms of the pain in lumbar and lower limbs.
Improvement of the range of movements in the Lumbar and lower limbs. |
45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of additional effects and siddha
parameters changes in Thandagavatham |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
27/02/2021 |
| 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="0"
Days="0" |
|
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
|
The study is a prospective open labelled phase II non-randomized clinical study to evaluate the therapeutic efficacy of Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis). The trial drug will be administered orally at the dose of 30 ml after the food, twice a day for a period of 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. |