| CTRI Number |
CTRI/2022/02/040374 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
16/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinica trial on VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM (CERVICAL SPONDYLOSIS) |
|
Scientific Title of Study
|
A prospective open labelled non Randomized phaseII clinical trial on VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(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 |
Sarumathi S |
| Designation |
Pg scholar |
| Affiliation |
Govt. Siddha Medical college and hospital, Palayamkottai. |
| Address |
, second year, Dept of Pothumaruthuvam, op no 10,Govt Siddha Medical college and hospital Palayamkottai Tirunelveli 627002.
second year,Dept of Pothumaruthuvam,Op No 10,Govt siddha medical college and hospital, palayamkottai Tirunelveli 627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7639531129 |
| Fax |
|
| Email |
mugamathi53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Komalavalli MD s Ph D |
| Designation |
Professor |
| Affiliation |
Govt. Siddha medical college and hospital, Palayamkottai |
| Address |
Professor,
Dept of pothu maruthuvam, op no 10,Govt siddha medical college and hospital Palayamkottai
Professor
Dept of pothumaruthuvam op no 10,Govt siddha medical college and hospital, Palayamkottai,
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD s Ph D |
| Designation |
HOD, Professor |
| Affiliation |
Govt siddha medical college and hospital palayamkottai |
| Address |
Head of the department, Dept of pothumaruthuvam, op no 10,Govt siddha medical college and hospital Palayamkottai
Head of the department, Dept of pothumaruthuvam, op no 10,Govt siddha medical college and hospital Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and
Central Library of Govt. Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical college and hospital, Palayamkottai, Tirunelveli, Tamilnadu |
| 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 |
| Sarumathi S |
Govt siddha medical college and hospital |
PG Department of Pothu Maruthuvam, OP no 10,Government Siddha medical college and hospital Palayamkottai,
Tirunelveli
TAMIL NADU |
7639531129
mugamathi53@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: M478||Other spondylosis, (2) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Vishnukiranthi kudineer |
30 to 60ml/twice a day (orally) 45 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain radiating to upper limb with or without numbness, guiddiness and neck stiffness
Restriction neck movememts
Willing for doing laboratory investigation and xray imaging
The neck diability index score should be equal or greater than 40% |
|
| ExclusionCriteria |
| Details |
Age less than 20 greater than 60
Traumatic injury
Systemic hyper tension
Ischeamic heart diseases
Chronic kidney disease
Tuberculosis of spine
Secondary maliganancy
Chronic systemic illness
Congenital spinal anomaly
Pregnancy
Lactating mother
Extra cervical rib. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction of the symptoms of painin neck and upper limbs
Improvement of the range of movements in the neck and upper limbs
The outcome is aimed at reducing pain and increasing the range of movements
Good improvement-score 10%/below10%
Moderate improvement-score10-20%
Mild improvement-score 20-30%
No improvement-score 40% |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the physicochemocal, phytochemicals, biochemical analysis of clinical trial drug
To evaluate the safety profile for acute and subacute toxicity of the trial drug
To evaluate Antimicrobial activity of the trial drug
To evaluate the pharmacological analysis of the clinical trial drug
To evaluate siddha parameters and compare the(including envagaithervu) changes in Ceganavadham during trial period
To evaluate modern parametric changes in Ceganavadham
To evaluate the efficacy of Vishnukiranti kudineer on ceganavadham by the bio statistical analysis. |
45 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)
|
28/02/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a Prospective Open labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 30-60 ml /twice a day (orally) 45 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary out come will be the evaluations of siddha diagnostic parameters, assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility |