| CTRI Number |
CTRI/2024/06/069586 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Uloga Suttigai for vathathambam |
|
Scientific Title of Study
|
An open single arm clinical trial to determine the effectiveness of Uloga Suttigai (Metal Cauterization) in the management of Vathathambam (Sciatica) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N A Adlinnivetha |
| Designation |
PG Scholer |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram
Tamil Nadu
600047
India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
7598657299 |
| Fax |
|
| Email |
adlinufiyabsms3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
D Periyasami |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram
Tamil Nadu
600047
India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
7358481734 |
| Fax |
|
| Email |
sami2011nis@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
D Periyasami |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram
Tamil Nadu
600047
India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
7358481734 |
| Fax |
|
| Email |
sami2011nis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar hospital
National Institute of Siddha
Tambaram sanatorium-600047
Kancheepuram
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room No 14 Department of Pura Maruthuvam National institute of Siddha Tambaram Sanatorium-600047
Kancheepuram district
|
| 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 N A Adlinnivetha |
Ayothidoss pandithar hospital |
Room no 14
Department of Puramaruthuvam
National Institute of Siddha
Tambaram sanatorium
Kancheepuram
Tamilnadu Kancheepuram TAMIL NADU |
7598657299
adlinufiyabsms3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Suttigai for Vathathambam |
The copper suttigai will heated upto red hot and to be touched at the tender points of affected site number of sitting maximum 5 times interval between the two procedure once in 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Presence of low back pain
2 Presence of burning pain numbness paresthesia and tingling sensation
3 A positive SLR test
4 Willing to give blood samples for investigation
5 Willing to take photographs
6 Willing to participate in trial and signing consent by fulfilling the condition of proforma
|
|
| ExclusionCriteria |
| Details |
Known history infective arthritis
Known history of fracture of malunion
History of uncontrolled diabetes mellitus
Pregnant and lactating women
Known case of limb weakness and foot drop
Chronic alcoholism
Psychiatric illness
Rheumatoid arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic effectiveness of Uloga suttigai for the management of sciatic pain will be determined by visual analogue scale and Oswestry low back disability index |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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
|
BACKGROUND The Siddha system of medicine is based on a combination of ancient medical practices and spiritual disciplines In the text Yugi vaythiya chinthamani Yugimunivar classified the Vadha disease as 80 types and Vadathambam is one among them.In modern medicine Vathathambam may be correlated with Sciatica Sciatica pain is the most common musculo skeletal conditions that have life time prevalence of up to 70 percentage and this seems to be increasing in incidences Sciatica is condition in which the patient experience pain and or paresthesias in the sciatic nerve distribution or an associated lumbo sacral nerve root the sciatic nerve is made up of the L4 through S2 nerve roots which coalesce at the pelvis to form the sciatic nerve At upto 2cm in diameter the sciatic nerve is easily largest nerve in the body Sciatic pain often is worsened with flexion of the lumbar spine twisting bending or coughing The sciatic nerve provides direct motor function to the hamstrings lower extremity adductors and indirect motor function to the calf muscle anterior lower leg muscle and some intrinsic foot muscles Also indirectly through its terminal branches the sciatic nerve provides sensation to the posterior and lateral lower leg and the plantar aspect of the foot The straight leg raise test is a passive examination Typically pain that is reproduced between 30 to 70 degrees of hip flexion and experienced primarily in the back is likely due to a lumbar disc herniation In modern medicine the condition is managed by electro therapy hydrotherapy and exercise therapy to the patients Suttigai is one of the 32 external medicines found in Siddha literatures under the topic Puramarunthugal Vathathambam is caused by vitiated Vatham In chronic condition Kabam also added with vitiated Vatham and produce severe symptoms and signs In Suttigai procedure is mostly used in chronic and severe symptoms This Suttigai procedure act over cutaneous receptor and first cause sharp pain through ascending pathway and activate the descending pathway endogenous analgesic system Periaqueductal grey matter PAGdorsal raphe nucleus nucleus raphe Magnus and medial reticular column which involves the various chemicals Suttigai therapy is non pharmocological cost effective economically non viable easy to perform even at remote areas for management of sciatica OBJECTIVE To study the therapeutic effectiveness of Uloga Suttigai (Metal cauterization) in reducing the clinical signs and symptoms of Vathathambam (Sciatica) through VAS scale and Oswestry low back Disability Index STUDY DESIGN An open single arm clinical trial with a total number of 30 diagnosed patient of Vathathambam Sciatica reporting at Ayothidoss Pandithar hospital National Institute of Siddha will be enrolled in the study patients having history of uncontrolled Diabetes Rheumatoid arthritis Chronic alcoholism Psychiatric illness Limb weakness Foot drop fracture infective arthiritis Pregnant and Lactating women will excluded The trial procedure suttigai will be given for 48 days |