| CTRI Number |
CTRI/2019/05/019003 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on Sangan Ilai Kudineer in the management of Cegana Vatham (Cervical Spondylosis) |
|
Scientific Title of Study
|
A Prospective Open labelled, Non-randomized Phase II clinical trial of SANGAN ILAI KUDINEER in the management of CEGANA VATHAM (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 |
S DHIVYA |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
II year PG Scholar Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220066540 |
| Fax |
|
| Email |
dhivyasundararajan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MDSiddha Ph D |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MDSiddha Ph D |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam 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
|
| IPD and OPD facilities and central library of Govt Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College and Hospital |
| Address |
Govt 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 |
| S DHIVYA |
Govt Siddha Medical and College |
OP no 10
PG Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
627002
Tirunelveli
TAMIL NADU |
8220066540
dhivyasundararajan1@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: M501||Cervical disc disorder with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sangan Ilai Kudineer |
100ml BD A/F for 45 days |
|
|
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 of neck movements.
3.Willing for doing X-ray imaging.
4.Neck disability index score should be equal or greater than 40%. |
|
| ExclusionCriteria |
| Details |
1.Traumatic injury
2.systemic hypertension
3. Diabetes Mellitus
4. Ischemic heart disease
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.Reduction of pain in neck and upper limbs
2.Improvement of the range of movements in the neck and upper limbs
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of pharmacological, biochemical and phytochemical analysis of trial drug
2. Determination of safety profile of trial drug
3. Evaluation of additional effects and siddha parameters changes in Cegana Vatham |
45days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/05/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective open labelled phase II non- randomized clinical study to evaluate the therapeutic efficacy of SANGAN ILAI KUDINEER in the management if Cegana vatham( Cervical spondylosis). The trial drug will be administered at the dose of 100 ml BD A/F for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu . The Primary outcome will be the evaluation of therapeutic efficacy of trial drug SANGAN ILAI KUDINEER. The secondary outcome will be the evaluation of Siddha diagnostic parameters, assessment of safety profile of trial drug,assessment of pharamocological and biochemical parameters of trail drug. |