| CTRI Number |
CTRI/2024/07/070302 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varma points Manipulation and Varma Thadaval Murai] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Treated of Sciatica with Varma points,Varma Thadaval Murai and chukku kashayam - III |
|
Scientific Title of Study
|
An open labelled triple arm non randomized phase II clinical trial,To compare the effectiveness of Varma Points Manipulation and Varma Thadaval Murai and chukku kashayam - III (Internal) in the management of Perasana Narambu Thabitham |
| 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 A DEEXIT THIRIVENI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Varma Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8056291928 |
| Fax |
|
| Email |
dr.deexitthiriveni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R VANAMAMALAI MDS |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Varma Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
drvanamamalai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R VANAMAMALAI MDS |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Varma Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
drvanamamalai@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD,IPD facilities and central library of Government Siddha Medical College and hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu,India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College And Hospital |
| Address |
No:2,Langargana street, Palayamkottai,Tirunelveli-627002,Tamilnadu,India |
| 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 A DEEXIT THIRIVENI |
Government Siddha Medical College and Hospital |
OPD no:14, IPD no:22&26, Department Of Varma Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU |
8056291928
dr.deexitthiriveni@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: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chukku kashayam III - Internal Medication |
Chukku kashayam III - 90 ml BD before food for 21 days |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Varma Points Manipulation - External therapy |
Manipulation of varma points done by applying firm pressure for 21 days ( 1 to 7 days -daily,8 to 21 days- thrice a week) |
| Intervention |
Varma Thadaval Murai-External therapy |
Done by massaging the affected area of the body with gentle pressure for 21 days( 1 to 7 day- daily,8 to 21 days - thrice a week) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Back pain with sciatica.
2.Sciatica from Lumbar intervertebral disc herniation as confirmed by MRI and neurologic examination.
3.Lumbar or pelvic muscular spasm
4.Patient willing to sign informed consent document
5.patient willing for admission and stay in IPD or willing to attend OPD. |
|
| ExclusionCriteria |
| Details |
1.Below 25yrs and above 65yrs
2.Spondylolisthesis
3.History of spinal operation,vertebral fracture or dislocation.
4.Conus medullaris syndrome
5.Cauda equina syndrome
6.Sacroilitis
7.Congenital anomalies
8.Spinal tumour
9.Pregnant women and lactating mothers
10.Patients with any other serious systemic illness
11.Patients who are having the skin disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain and improvement in range of movements will be assessed by Roland Morris Disability Questionnaire(RMDQ) and Paraesthesia and Numbness will be assessed by Leeds Assessment of Neuropathic symptoms and signs (LANSS) |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
25/07/2024 |
| 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="6"
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
|
This study is an open labelled triple arm non randomized phase II clinical trial to compare the effectiveness of Varma Points Manipulation(external therapy), Varma Thadaval Murai(external therapy) and Chukku kashayam-III(internal) in the management of Perasana Narambu Thabitham. The manipulation of Varma Points will be done continuously for first one week and thrice a week for 8 to 21 days. The Varma Thadaval Murai will be done by massaging continuously for first one week and thrice a week for 8 to 21 days. The dosage of internal medication Chukku kashayam-III is 90 ml (BD) and will be administered before food for 21 days. The sample size of the study is 90 which will be categorized in to 3 groups of each 30. The first group will be given with Varma Points Manipulation only. The second group will be given with Varma Thadaval Murai only. The third group will be given with internal medication only.
|