| CTRI Number |
CTRI/2018/03/012711 [Registered on: 21/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/02/2018 |
| 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 INJI CHOORANAM on Cegana Vatham (Cervical Spondylosis) |
|
Scientific Title of Study
|
A prospective open labeled randomized clinical trial on Cegana Vatham (Cervical Spondylosis) with evaluation of trial drug "Inji Chooranam " |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Nahitha Lubana |
| Designation |
PG Student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Op number 10
Department of Pothu Maruthuvam Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865863631 |
| Fax |
|
| Email |
drnahitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical college and hospital
Palayamkottai
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Library
Government Siddha Medical college and hospital
Palayamkottai |
| OPD and IPD
Government Siddha Medical college and hospital
Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi |
| Address |
Principal
Government Siddha Medical college and hospital
Palayamkottai |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| A Nahitha Lubana |
Government Siddha Medical College and hospital |
Op number 10
PG Department of Pothu Maruthuvam
Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9865863631
drnahitha@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 |
Cegana Vatham , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJI Chooranam |
1g orally bd with warm water for 48 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with appropriate symptoms of neck pain radiating to upper limb with or without numbness giddiness neck stiffness and restricted neck movements Willing for doing laboratory investigations and x Ray imaging Neck stability index score should be equal or greater than 60% |
|
| ExclusionCriteria |
| Details |
Extra cervical rib trauma
Systemic hypertension
Diabetes mellitus
Chronic kidney disease
Tuberculosis in spine
Ischemic heart disease
Pregnancy
Lactating mother
Neoplasams
Patient with any other chronic illness
Systemic illness
Congenital spinal anomalies
Malignancy secondaries |
|
|
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 Inji Chooranam on Cegana Vatham |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters |
48 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)
|
08/07/2017 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is prospective open Labeled randomized phase II clinical trial to evaluate the therapeutic efficacy of Inji Chooranam 1g bd with warm water for 48 days in 40 Patients during the trial period of 6 months that will be conducted in Government Siddha Medical college and hospital Palayamkottai Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug Inji Chooranam on Cegana Vatham The secondary outcome will be the evaluation of Siddha diagnostic parameters |