| CTRI Number |
CTRI/2020/03/024166 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
14/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of varmam, aanai thipili dhravagam (internal) and kayathirumeni ennai (external) for Thandagavadham (lumbar spondylosis) |
|
Scientific Title of Study
|
An open clinical evaluation on THANDAGAVADHAM (Lumbar Spondylosis) treated with VARMAM and AANAI THIPILI DHRAVAGAM (Internal) and KAYATHIRUMENI ENNAI (External) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parameswari Arumugam |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college |
| Address |
PG scholar, department of Varmam maruthuvam, Government siddha medical college, Anna arch road, NSK nagar, Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
7358456402 |
| Fax |
|
| Email |
paramesanjali26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Mohammed Mustafa |
| Designation |
Professors |
| Affiliation |
Government siddha medical college |
| Address |
Department of Varmam maruthuvam, Government siddha medical college, Anna arch road, NSK nagar, Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9840151147 |
| Fax |
|
| Email |
musthafahod1122@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mohammed Mustafa |
| Designation |
Professors |
| Affiliation |
Government siddha medical college |
| Address |
Department of Varmam maruthuvam, Government siddha medical college, Anna arch road, NSK nagar, Arumbakkam
TAMIL NADU
600106
India |
| Phone |
9840151147 |
| Fax |
|
| Email |
musthafahod1122@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI. |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college chennai |
| Address |
Department of varmam maruthuvam, Government siddha medical college, Anna arch road, Arumbakkam, Chennai-600106 |
| 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 |
| Parameswari |
Government Siddha Medical College |
Anna arch road, NSK nagar, Armbakkam
Chennai
TAMIL NADU |
7358456402
paramesanjali26@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: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aanai thipili dhravagam (internal) and Kayathirumeni ennai (external) |
2 ml of Aanai thipili dhravagam given along with 30 ml of water for twice a day after a meal for 21 days and externally kayathirumeni ennai given for application over the affected area for 21 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having any one of the symptoms of lower back pain radiating to the lower extremities anteriorly, tenderness, numbness. Limitation of lower back movements. Patients who is willing to undergo necessary investigations.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pain is assessed by Visual Analogue Scale,Improvement in range of movements, stiffness is assessed by using Oswestry Disability Index. Comparing the clinical symptoms and physical examinations before and after treatment.
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by comparing safety profile before and after treatment. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/03/2020 |
| 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)?
|
|
Brief Summary
|
This is a phase II, non-randomized, comparative an open clinical evaluation of Varmam and Siddha trial drugs "Aanai thipili dhravagam" (internal) and "Kayathirumeni ennai" (external) for Thandagavadham (lumbarspondylosis). The dosage of internal medication Aanai thipili dhravagam is 2 ml along with 30ml of water and will be administered twice a day after a meal. The time period of medication will be around 21 days and a sufficient amount of Kayathirumeni ennai will be given for 21days . The sample size for this study is 90 which will be categorized into 3 groups. The first group will be given Varmam therapy, the second group will be given both internal and external medication and the final group will be given internal, external and varmam therapy. The trial drug Aanai thipili dhravagam contains some active herbs that possess anti-inflammatory, analgesic which will be helpful to reduce the symptoms of Lumbar spondylosis. |