| CTRI Number |
CTRI/2018/05/013642 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
02/05/2018 |
| 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 trial drug Pooranathi Chooranam (INT),Vali Kuthaluku Ulli Ennai (EXT)and Ottradam in patients having neck pain |
|
Scientific Title of Study
|
An open clinical evaluation on Saganavatham (Cervical spondylosis) with siddha herbal formulation drug Pooranathi chooranam (Int), Vali kuthaluku Ulli Ennai (Ext) and Ottradam |
| 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 Kalaivani |
| 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 |
9786725977 |
| Fax |
|
| Email |
kalaivanibsms92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGSekar |
| Designation |
Grade II Lecturer |
| 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 |
9786193863 |
| Fax |
|
| Email |
guidesekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Kalaivani |
| 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 |
9786725977 |
| Fax |
|
| Email |
kalaivanibsms92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,N0 6 Anna arch road, NSK Nagar, Arumbakkam, Chennai 106. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
PG Sirappu Maruthuvam, 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 Kalaivani |
Government siddha medical college |
Room no 4 dept of sirappu maruthuvam, Govt siddha medical college
6th Anna arch road
NSK Nagar
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU |
9786725977
kalaivanibsms92@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 |
| Comparator Agent |
nil |
nil |
| Intervention |
Pooranathi chooranam (Internal) and vali kuthaluku Ulli Ennai (External) |
20 patients treated with 1-2grams of Pooranathi chooranam with honey twice daily as internal medicine and vali kuthaluku ulli ennai as external medicine for 48 days. |
| Intervention |
Pooranathi chooranam (Internal), vali kuthaluku Ulli Ennai (External) and ottradam (Therapy) |
20 patients treated with 1-2grams of Pooranathi chooranam with honey twice daily as internal medicine, vali kuthaluku ulli ennai as external medicine,Ottradam supporting therapy for 48 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Complain about dull pain behind the neck in the area of trapezius
2.Radiating pain to the upper limbs
3. Numbness and weakness in arms, hands and fingers
4.Giddiness
5.Muscle spasms in neck and shoulders
|
|
| ExclusionCriteria |
| Details |
History of
1.Cervical rib
2.Trauma
3.Spina bifida
4.Cardiac disease
5.Fracture
6.Ankylosing spondylosis (stright spine)
7.Malignancy
8.Pregnancy and Lactation
9.Tuberculosis in spine
10.Adhesive capsulitis
11.Carpal tunnel syndrome
12.Patient 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 by assessed Visual analog scale. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/05/2018 |
| 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
|
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 Pooranathi chooranam (Internal) and Vali kuthaluku Ulli Ennai (External)... Pooranathi chooranam and sufficient quantity of Vali kuthaluku Ulli Ennai will be given for 48 days. Ottradam therapy is given for all the patients. Sample size is 40. The trial drugs Pooranathi chooranam and vali kuthaluku Ulli Ennai contain some active herbs having anti inflammatory and analgesic properties which will be cure Cervical spondylosis.
|