| CTRI Number |
CTRI/2024/06/068763 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cervical spondylosis - An oral administration of classical siddha drug Kanduparangi chooranam |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non-randomized, single centric, phase II clinic trail to determine the effectiveness of kanduparangi chooranam in the management of ceganavatham (cervical spondylosis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K ROHINI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government siddha medical College, Palayamkottai. |
| Address |
Op no. 10,
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7598599337 |
| Fax |
|
| Email |
krohinibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Justus Antony |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College, Palayamkottai |
| Address |
Op no.10,
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College, Palayamkottai |
| Address |
Op no.10,
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital, Palayamkottai,
Tirunelveli-627002,
Tamilnadu,
India.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248497477 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli - 627002,
Tamilnadu,
India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli,
627002. |
| 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 K ROHINI |
Government Siddha Medical College and Hospital |
Op no.10,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli - 627002,
Tamilnadu,
India.
Tirunelveli
TAMIL NADU |
7598599337
krohinibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College, Palayamkottai |
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 |
| Intervention |
KANDUPARANGI CHOORANAM |
3 gms (Twice a day orally with hot water before food for 45 days) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck pain radiating ro upper limb without numbness, giddiness and neck stiffness
2. Restricted 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 and 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 |
1. The outcome is aimed at reducing pain and increasing range of movement.
2. Reduction of OSWESTRY DISABILITY INDEX score to 10 points on comparison with OSWESTRY DISABILITY INDEX score prior to the treatment. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate 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 Kanduparangi chooranam on ceganavatham by the biostatistical analysis |
6 months |
|
|
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)
|
25/06/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRAIL TO DETERMINE THE EFFECTIVENESS OF KANDUPARANGI CHOORANAM IN THE MANAGEMENT OF CEGANAVATHAM (CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 3gms twice a day orally with hot water for 45 days on 40 (20 OP + 20 IP) 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 determining the clinical effectiveness of KANDUPARANGI CHOORANAM on CEGANAVATHAM (CERVICAL SPONDYLOSIS). The secondary outcome will be evaluating the siddha diagnostic parameters, assessment of pharmacological and biochemical parameters of trial drug. Incase of any Adverse Events (AE) noticed, it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility. |