| CTRI Number |
CTRI/2018/02/011686 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on siddha trail drug Kurunthotti Kashayam (Int) Azhinjil Thylam (Ext) and Varmam in patients having neck pain |
|
Scientific Title of Study
|
An open comparative clinical evaluation on Saganavatham (Cervical spondylosis) with siddha herbal formulation drug Kurunthotti Kashayam (Int) Azhinjil Thylam (Ext) and Varmam |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Rasakumar |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of Sirappu Maruthuvam
Government Siddha Medical College No 6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9843172369 |
| Fax |
|
| Email |
rasakumar29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Mohamed Musthafa |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of Sirappu Maruthuvam
Government Siddha Medical College No 6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444190077 |
| Fax |
|
| Email |
spmhibiscus@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Rasakumar |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of Sirappu Maruthuvam
Government Siddha Medical College No 6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9843172369 |
| Fax |
|
| Email |
rasakumar29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
No 6 Anna Arch road
NSK Nagar
Arumbakkam
Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No 6 Anna Arch road
NSK Nagar
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 R Rasakumar |
Arignar Anna Hospital of Indian Medicine |
Room No 4 Siddha Division
Post Graduate Department of Sirappu Maruthuvam
Arignar Anna Hospital of Indian Medicine Anna arch road
NSK Nagar
Arumbakkam
Chennai 106
Chennai
TAMIL NADU |
9843172369
rasakumar29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Saganavatham (Cervical spondylosis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kurunthotti kashayam (Internal) and Azhinjil Thylam (EXternal) |
60 ml of kurunthotti kashayam for 48 days as internal medcine and Azhinjil thylam for 48 days as external medicine |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain in the nape of the neck
2. Radiating pain to the upper limbs up to the tip of the fingers with or without numbness in the upper limbs
3. Giddiness
4. Neck stiffness |
|
| ExclusionCriteria |
| Details |
History of
1.Trauma.
2. Thoracic outlet syndrome.
3. Cervical IVDP.
4. Congenital anomalies of spine like Torticolis,
Spina bifida & scoliosis.
5. Sero Negative Spondylarthropathy like
Ankylosing spondylitis, Polyarthritis etc…
6. Syringomyelia.
7. Tuberculosis of spine
8. Neuropathic arthropathy in Diabetes mellitus
9. Cardiac diseases
10. Neoplasms
11. Pregnancy & Lactation
12. Patients with any other serious systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is reduction of pain in neck which is assessed by Visual analog scale |
nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
10/07/2017 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open clinical study to evaluate the efficacy of Kurunthotti Kashayam (Internal) and Azhinjil Thylam (External). 60 ml of Kurunthotti kashayam and sufficient quantity of Azhinjil Thylam will be given for 48 days. Varmam therapy is given for all the patients.Sample size is 60. The trial drugs Kurunthotti Kashayam and Azhinjil Thylam contain some active herbs having anti inflammatory and analgesic properties which will be helpful to cure Cervical spondylosis |