| CTRI Number |
CTRI/2019/05/019064 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Marutham Pattai Chooranam in the management of Thandaga Vatham(Lumbar spondylosis) |
|
Scientific Title of Study
|
A Prospective Openlabelled, Non- randomized,Phase II clinical trial of
Marutham Pattai Chooranam 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 |
D Nesanthine |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Scholar
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
8489889079 |
| Fax |
|
| Email |
devadasnisha5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T komalavalli MD PhD |
| Designation |
Associate professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T komalavalli MD PhD |
| Designation |
Associate professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD Facilities and Central Library of Government Siddha Medical College and Hospital
Palayamkottai
|
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Palayamkottai
627 002
Tirunelveli
Tamilnadu
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 |
| D Nesanthine |
Government Siddha Medical College and Hospital Palayamkottai |
OP number 10
PG Department of PothuMaruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
Tirunelveli
TAMIL NADU |
8489889079
devadasnisha5@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 |
| Intervention |
Marutham pattai chooranam |
35mg/kg/BW/ twice a day after food with hot water orally for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical symtoms of lumbar spondylosis
2. Patients with low back pain with radiograph of lumbosacral spine showing
a.loss of natural lumbar lordosis
b.Reduction in disc space
c.formation of osteophytes
d.osteoporosis
e.subluxation of vertebra
3. |
|
| ExclusionCriteria |
| Details |
1.pregnant women
2.TB of spine
3.Systemic Lupus Erythematosus
4.Congenital scoliosis,kyphosis
5.Patients in treatment for any other system of medicine for the same problem during clinical trials
6.Patients with lumbar spondylosis need in other emergency treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Reduction in clinical symptoms of Lumbar Spondylosis |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Determination of safety profile,Pharmacological and bio chemical parameters of trial drug
2.Evaluation of additional effects and siddha parameters changes in Thandaga Vatham |
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)
|
13/05/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is prospective,open labelled,non-randomized phae II clincal study to evaluate the therapeutic efficacy of MARUTHAM PATTAI CHOORANAM in the management of Thandaga vatham (Lumbar Spondylosis).The trial drug will be administered at the dose of 35mg/kg/BW/twice a day orally A/F along with hot water as adjuvant for 45 days in 60 patients(30 in OPD +30in IPD).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 the evaluation of therapeutic efficacy of the trial drug Marutham Pattai Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters assessment of safety profile of trial drug, assessment of pharamcological and biochemical parameters of the trial drug |