| CTRI Number |
CTRI/2014/04/004569 [Registered on: 25/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of poopathi maathirai (internal) and kadugu ennai (external) for the management of ceganavatham (cervical spondylosis) |
|
Scientific Title of Study
|
An Open Clinical trial to evaluate the safety and therapeutic efficacy of Poopathi maathirai (internal) and Kadugu ennai (external) for the management of 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 P S THIRUVARUL KAMALA ARUMUGAM |
| Designation |
PG SCHOLAR |
| Affiliation |
National institute of siddha |
| Address |
DEPARTMENT OF SIRAPPU MARUTHUVAM,NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
8925841776 |
| Fax |
|
| Email |
drthiruvarulmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GTHIYAGARAJAN |
| Designation |
HOD AND GUIDE |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF SIRAPPU MARUTHUVAM,
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
8056074770 |
| Fax |
044-22381314 |
| Email |
gtsiddha60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VMAHALAKSHMI |
| Designation |
MD SIDDHA |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF SIRAPPU MARUTHUVAM,
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
8148610434 |
| Fax |
044-22381314 |
| Email |
maharm78@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIM,
CHENNAI-47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 THIRUVARUL KAMALA ARUMUGAM |
NATIONAL INSTITUTE OF SIDDHA |
DEPARTMENT OF SIRAPPU MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Chennai
TAMIL NADU |
8925841776
044-22381314
drthiruvarulmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CEGANAVATHAM(CERVICAL SPONDYLOSIS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
POOPATHI MAATHIRAI (INTERNAL MEDICINE)&KADUGU ENNAI (EXTERNAL MEDICINE) |
260mg of Poopathi maathirai wiil be administered orally with ginger juice twice a day for 48 days and the sufficient quantity of external medicine Kadugu ennai to be applied on the affected parts daily. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age: between 20 years and 60 years
• Sex: Both Male and Female
• Willing to participate in trial and signing consent by fulfilling the conditions of Proforma
• Neck pain
• Radiating pain to the upper limbs
• With or without numbness in the upper limbs
• Giddiness and
• Neck stiffness
• Willing for doing laboratory investigations and X-Ray imaging.
|
|
| ExclusionCriteria |
| Details |
• Cervical rib
• Trauma
• Spina bifida
• Diabetes mellitus
• Ankylosing spondylosis
• Tuberculosis in spine
• Cardiac diseases
• Pregnancy and lactation
• Neoplasms
• Patients with any other serious systemic illness
• Congenital anomalies of spine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PAIN IS ASSESSED BY UNIVERSAL PAIN ASSESMENT SCALE |
Before treatment and After treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and restriction of movements. |
48days |
|
|
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)
|
07/01/2014 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
STILL NO PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an Open clinical trial, to evaluate the therapeutic efficacy of Poopathi maathirai (internal medicine) a comibnation of 3 mineral drugs and 5 herbal drugs and Kadugu ennai (External medicine) a combination of herbal drugs taken from the siddha texts Veeramamunivar Vagada thirattu-suram manjari & Koshayi Anupoga vaithya Bhramma ragasiyam. 260 mg of Poopathi maathirai administered orally twice a day with Ginger juice and Kadugu ennai to be applied externally.The treatment will be given for 48 days.The Laboratory investigations and Clinical assessments will be recorded periodically before and after treatment period. All the trial related data will be recordered in Case Report Form (CRF) for each patient separately.At the end of trial all the data will be analysed statistically and the research reports will be Published . |