FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
Close