| CTRI Number |
CTRI/2022/02/040178 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
08/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Nochi ver kudineer in the management of Thandagavadham(Lumbar spondylosis) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL ON NOCHI VER KUDINEER IN THE MANAGEMENT OF THANDAGAVADHAM(LUMBAR 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 N Malarkodi |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu.
Department of Pothu Maruthuvam, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8056917813 |
| Fax |
|
| Email |
malarkodinuak98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subashchandran MDsPhD |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu.
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu.
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli,Tirunelveli-627002.
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 Government 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 |
| Dr N Malarkodi |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu.
Tirunelveli
TAMIL NADU |
8056917813
malarkodinuak98@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 |
, (1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
NOCHI VER KUDINEER |
30-60ml/twice a day(orally) 45 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggregating on forward and backward bending 2.SLR test positive patients 3.Patient complaining of back pain functional scale score should be range from below 30 4.Willing to participate in the clinical trial 5.Patient confirmed radiological diagnosis in Lumbar spondylosis |
|
| ExclusionCriteria |
| Details |
1.Age below 30 and above 60 2.Tuberculosis of spine 3.SLE 4.Chronic kidney disease 5.Fracture of spine 6.Congenital spinovertebral deformities 7.Mixed connective disease 8.Pregnancy 9.Lactating mother 10.Chronic Liver disease |
|
|
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 the pain in lumbar and lowwr limbs 2.Improvement of the range of movements in the lumbar and lower limbs 3.The outcome is aimed at reducing the pain and the range of the movements
Good improvement - score 10% or below 10%
Moderate improvement - score 10-20%
Mild improvement - score 20-30%
No improvements score 40% |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the physicochemical, phytochemical bio chrmical analysis of clinical trial drug
2.To evaluate the safety profile for acute and subacute toxicity of the trial drug.
3.To evaluate Antimicrobial activity of trial drug
4.To evaluate the pharmacological analysis of the clinical trial drug
5.To evaluate siddha parameters and compare the (including envagaithervu)changes in Thandagavadham during trial period
6.To evaluate modern parametric changes in Thandagavadham
7.To evaluate the efficacy of Nochi ver kudineer on Thandagavadham 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)
|
13/02/2022 |
| 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 NOCHI VER KUDUNEER in the management of THANDAGAVADHAM (LUMBAR SPONDYLOSIS).The trial drug will be administered at the dose of 30-60ml/ 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 outcome will be evaluation of therapeutic efficacy of the trial drug NOCHI VER KUDINEER. The secondary outcome 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) is noticed and it will be referred to pharmacovigilance department of SCRI . Further management of patients will be given in OPD facility. |