| CTRI Number |
CTRI/2017/05/008575 [Registered on: 16/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of drug Ayakantha Chendhooram for patients having low back pain |
|
Scientific Title of Study
|
A clinical study on vathasthambam wiyh evaluation of siddha drug "aya kaantha chendhooram" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KR MUTHUMARI |
| Designation |
Pg scholar |
| Affiliation |
Govt.siddha medical college |
| Address |
Dept.of Pothu Maruthuvam,Govt.siddha medical college,
Chennai
TAMIL NADU
600106
India |
| Phone |
9629291574 |
| Fax |
|
| Email |
drmuthumarikrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kanakavalli |
| Designation |
Professor |
| Affiliation |
Govt.siddha medical college |
| Address |
Govt Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
dr.kkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Kanakavalli |
| Designation |
Professor |
| Affiliation |
Govt.siddha medical college |
| Address |
Govt Siddha medical college,Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
dr.kkanakavalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT SIDDHA MEDICAL COLLEGE , ARUMBAKKAM |
|
|
Primary Sponsor
|
| Name |
GOVT SIDDHA MEDICAL COLLEGE |
| Address |
DEPT OF POTHU MARUTHUVAM, GOVT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
| 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 KR Muthumari |
Arignar Anna Government Hospital of Indian Medicine and Homeopathy |
Room No 1, Siddha division, PG General Medicine Department, Arignar Anna Hospital of Indian Medicine and Homeopathy, Arumbakkam, Chennai 106
Chennai
TAMIL NADU |
9629291574
drmuthumarikrishnan@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 |
Vathasthambam (Sciatica), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AYA KAANTHA CHENDHOORAM |
AYA KAANTHA CHENDHOORAM, 100mg, BD 48days orally with chukku thool |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients having pain in back or leg that is worsened while sitting
2.burning or tingling sensation down the leg,
weakness,numbness,difficulty moving the leg or foot
3.A constant pain on one side of the back
4. Patients having positive SLR Test |
|
| ExclusionCriteria |
| Details |
1.Patients of age below 18 above 60 years
2.Fracture of vertebral
3.Dislocation of vertebral
4.Deformities and congenital defects
5.Known case of TB of spine
6.Known case of neoplasam of spine pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Out come of treatment is assessed by reduction in symptoms and this will be considered as successive measures |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
21/09/2016 |
| 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) |
Open to Recruitment |
|
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 single single arm open clinical trial to study the safety and efficacy of Siddha trial drug Ayakantha chendhooram. The trial drug is given 100 milli grams twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Ayakantha chendhooram is mentioned in Nasakanda venba . During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |