| CTRI Number |
CTRI/2019/06/019695 [Registered on: 17/06/2019] Trial Registered Prospectively |
| Last Modified On: |
12/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
The study of Siddha drug Sirupanchamoola kiyazham, Thirumeni Ennai and Varmam therapy in patients having Saganavadam (Cervical Spondylosis) |
|
Scientific Title of Study
|
PHASE II OPEN, COMPARATIVE NON RANDOMIZED CLINICAL EVALUATION OF VARMAM THERAPY AND SIDDHA DRUG “SIRUPANCHAMOOLA KASAYAM (INTERNAL), THIRUMENI ENNAI (EXTERNAL) IN SAGANAVADAM (CERVICAL SPODYLOSIS) – PATIENTS ATTENDING VARMAM DEPARTMENT OF ANNA HOSPITAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mangaiarkarasi P |
| Designation |
P.G Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of PG Varmam Maruthuvam
Government Siddha Medical College
6 Anna Arch Road
NSK Nagar
Arumbakkam Chennai
Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9442666859 |
| Fax |
|
| Email |
mangainarayanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Musthafa |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of PG Varmam Maruthuvam
Government Siddha Medical College
6 Anna Arch Road
NSK Nagar
Arumbakkam Chennai
Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444190077 |
| Fax |
|
| Email |
profmustafahod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mangaiarkarasi P |
| Designation |
P G Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of PG Varmam Maruthuvam
Government Siddha Medical College
6 Anna Arch Road
NSK Nagar
Arumbakkam Chennai
Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9442666859 |
| Fax |
|
| Email |
mangainarayanan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
PG Varmam Maruthuvam
Government Siddha Medical College
6 Anna Arch Road
NSK Nagar
Arumbakkam Chennai
Tamil Nadu |
| 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 |
| Mangaiarkarasi P |
Arignar Anna Hospital of Indian Medicine |
Department of Varmam Maruthuvam
Government Siddha Medical College
6 Anna Arch Road
NSK Nagar
Arumbakkam Chennai
Tamil Nadu
Chennai
TAMIL NADU |
9442666859
mangainarayanan@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 |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
SIRUPANCHAMOOLA KIYAZHAM, THIRUMENI ENNAI and VARMAM THERAY |
SIRUPANCHAMOOLA KIYAZHAM: 100 ml +1g Thippili podi; Twice Daily; 6 days,THIRUMENI ENNAI: 10 ml gently applied over the neck region and VARMAM THERAPY |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Complain about dull pain behind the neck in the area of trapezius
Radiating pain to the upper limbs
Numbness and weakness in arms, hands and fingers
Giddiness
Muscle spasms in neck and shoulders
|
|
| ExclusionCriteria |
| Details |
Trauma
Cervical rib
Ankylosing spondylosis
Cardiac disease
Fracture
Adhesive capsulitis
Caries spine
Patient with any other serious systemic illness
Malignancy
Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of the treatment is assessed by neck disability index, Nurick Classification scoring system, chin test, spurling test, range of movement |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
48 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)
|
20/06/2019 |
| 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 an open clinicla study to evaluvate the efficacy of sirupanchamoola kiyazham iInternal trial drug of 100 ml + 1 g Thippilipodi given twice for 6 days and 10 ml external drug applied over the neck and Varmam therapy is given for 60 patients in Anna hospital |