CTRI Number |
CTRI/2019/08/020779 [Registered on: 20/08/2019] Trial Registered Prospectively |
Last Modified On: |
16/08/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Other |
Public Title of Study
|
Clinical evaluation of Siddha drug Sanmuga mezhugu in low back ache (sciatica). |
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of Siddha drug "SANMUGA MEZHUGU" for vathathambam (sciatica) - in both gender age between 25 TO 60 years patients attending opd at AAGHIM attached with GSMC. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr SUSHMITHA S |
Designation |
PG Scholar |
Affiliation |
Government Siddha medical college |
Address |
Post graduate department of General medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Post Graduate Department of General Medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Chennai TAMIL NADU 600106 India |
Phone |
8807012499 |
Fax |
|
Email |
sushmithasrini9194@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anbu N |
Designation |
HOD and Professor |
Affiliation |
Government Siddha medical college |
Address |
Post graduate department of General medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Post graduate department of general medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Chennai TAMIL NADU 600106 India |
Phone |
9443279412 |
Fax |
|
Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr SUSHMITHA S |
Designation |
PG Scholar |
Affiliation |
Government Siddha medical college |
Address |
Post graduate department of general medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Post Graduate Department of General Medicine
Government Siddha medical college
No 6 Anna arch road NSK Nagar
Arumbakkam
Chennai -106 Chennai TAMIL NADU 600106 India |
Phone |
8807012499 |
Fax |
|
Email |
sushmithasrini9194@gmail.com |
|
Source of Monetary or Material Support
|
No 6 Anna arch road
Government Siddha medical college
arumbakkam
chennai -106 |
|
Primary Sponsor
|
Name |
Government Siddha medical college |
Address |
No 6 anna arch road
Government Siddha medical college
arumbakkam
chennai-106 |
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 SUSHMITHA S |
Aringar Anna Government Hospital of Indian Medicine |
Room no 2
Department of Siddha
no 6 anna arch road
Arumbakkam
Chennai -106
Chennai TAMIL NADU |
8807012499
sushmithasrini9194@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
nil |
nil |
Intervention |
Sanmuga mezhugu |
100mg twice a day with palm jaggery for 35 days with intermittent 7 days gap. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients having pain in the low back or leg
Burning or tingling sensation present in the posterior and lateral aspect of the leg
Weakness, numbness and difficulty in moving the leg or foot
A constant pain on one side of the back
A positive SLR test |
|
ExclusionCriteria |
Details |
Fracture of vertebrae
Dislocation of vertebrae
Deformities and congenital defects
Known case of tuberculosis of spine
Known case of neoplasm of spine
Pregnancy and lactating women
Multiple myeloma
Patients of age below 25 above 60 years
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome of treatment is mainly assessed by reduction in clinical symptoms measured by using Roland-Morris disability scale |
35 days with intermittent 7 days gap |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcome of treatment is assessed by comparing the safety parameters before and after treatment |
35 days with intermittent 7 days gap |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
21/08/2019 |
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
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a Non randomized open clinical trail to study the safety and efficacy of Siddha drug Sanmuga mezhugu. The drug is given 100mg twice a day for 35 days with intermittent 7 days gap. Clinical trail is conducted after conducting Pre clinical toxicity study. The trail drug Sanmuga mezhugu is mentioned in Anuboga vaithya navaneetham part 7. During the trail all the study related data will be recorded and documented. After the completion of trail all the data will be analysed statistically. |