| CTRI Number |
CTRI/2023/05/052605 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| 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 chitramanakku ilai chooranam in the management of ceganavatham(cervical spondylosis) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED SINGLE ARM NON RANDOMIZED SINGLE CENTRIC PHASE II CLINICAL TRIAL ON CHITRAMANAKKU ILAI CHOORANAM IN THE MANAGEMENTOF CEGANAVATHAM(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 s senthamil veni |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital,palayamkottai |
| Address |
Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870233762 |
| Fax |
|
| Email |
drveni94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Uma kalyani MDs |
| Designation |
Lecturer Gr-II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072685509 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDs PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli
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 Gvernment Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli-627002
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 S Senthamil veni |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU |
8870233762
drveni94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITIEE GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHITRAMANAKKU ILAI CHOORANAM |
2mg Twice a day (orally)
Honey/Ghee
45days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Neck pain radiating to upper limb with or without numbness, giddiness and neck stiffness
2.Restriction neck movements.
3.Willing for doing laboratory investigations and X-Ray imaging.
4.The neck disability Index score should be equal or greater than 40%
|
|
| ExclusionCriteria |
| Details |
1.Age : Below 20 Years, Above 60 years
2.Traumatic injury
3.Systemic hypertension
4.Ischemic heart diseases
5.Chronic kidney disease
6.Tuberculosis in spine
7.Secondary malignancy
8.Chronic systemic illness
9.Congenital spinal anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of the symptoms of pain in neck and upper limbs
Improvement of the range of movements in the neck and upper limb
The outcome is aimed at reducing pain and increasing the range of movements
Good improvement-score10%below10%
Moderate improvement-score10-20%
Mild improvement-score20-30%
No improvement-score40% |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the physicochemical,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 ceganavatham during trial period
To evaluate modern parametric changes in ceganavatham
To evaluate the efficacy of chitramanakku ilai chooranam on ceganavatham by the bio statistical analysis |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/08/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 single arm non randomized single centric phase II non randomized clinical study to evaluate the therapeutic efficacy of CHITRAMANAKKU ILAI CHOORANAM in the management of CEGANAVATHAM(CERVICAL SPONDYLOSIS).The trial drug will be administered at the dose of 2mg/twice a day(orally)45 days in 40patients.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 the evaluations of siddha diagnostic parameters,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. Furthur management of patients will be given in OPD facility. |