| CTRI Number |
CTRI/2018/03/012681 [Registered on: 20/03/2018] Trial Registered Prospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to study the drug Appalakara chooranam on Vatham |
|
Scientific Title of Study
|
A Prospective open labelled phase II non randomized clinical trial on mineral drug of Appalakara Chooranam for the treatment of Cegana vatham (Cervical Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pasupathy Thavakeethan |
| Designation |
PG Student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam PG II Year Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220898759 |
| Fax |
|
| Email |
pasupathythavakeethan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD Siddha |
| Designation |
Head of the Department and Professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD Siddha |
| Designation |
Head of the Department and Professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support Library Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 |
| OPD and IPD Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 |
|
|
Primary Sponsor
|
| Name |
Dr R Neelavathy MD Siddha PhD |
| Address |
Principal Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 Tamilnadu India |
| 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 Pasupathy Thavakeethan |
Government Siddha Medical College |
Opd room 10 PG pothumaruthuvam Government Siddha Medical College and hospital Palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU |
8220898759
pasupathythavakeethan@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 |
Cegana Vatham, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Applakara Chooranam |
30mg/kg/BW/daily twice times per day with water |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain radiating to upper limb with or without numbness giddiness and neck stiffness
Restriction neck movement
Willing for doing laboratory investigations and x ray imaging
The neck disability index score should be equal or greater then 40 present |
|
| ExclusionCriteria |
| Details |
Traumatic injury
Systemic hypertension
Ischemic heart diseases
Chronic kidney disease
Tuberculosis in spine
Secondary malignancy
Chronic systemic illness
Congenital spinal anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug Appalakara chooranam on Cegana Vatham |
The therapeutic efficacy of trial drug Appalakara chooranam on Cegana Vatham |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters |
30 days |
|
|
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)
|
30/03/2018 |
| 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="6"
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
|
The Study is A prospective open labelled phase II non randomized clinical trial to evaluate the therapeutic efficacy of mineral drug of Appalakara Chooranam for the treatment of Cegana Vatham 30mg kg BW daily twice time per day with water for 30 days in 40 patients during the trial period of 18 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic efficacy of trial drug Appalakara Chooranam on Cegana Vatham The Secondary outcome will be the evaluation of siddha diagnostic parameters |