| CTRI Number |
CTRI/2023/08/056634 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study On Milaghu Legiyam And Kunthiriga Thailam In The Management Of Vathasthambam |
|
Scientific Title of Study
|
An Open Non Randomized Clinical Trial to evaluate the therapeutic effectiveness of Milaghu Legiyam (Internal) And Kunthiriga Thailam (External) in the management of Vathasthambam (Sciatica) in patients reporting at Ayothidoss Pandithar Hospital-OPD, National Institute of Siddha. |
| 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 S Dharshini |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6374290636 |
| Fax |
22381314 |
| Email |
dharshiniselvarasu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
22381314 |
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Dharshini |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6374290636 |
| Fax |
22381314 |
| Email |
dharshiniselvarasu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha Tambaram Sanatorium Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Chennai 600047 |
| 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 S Dharshini |
National Institute of Siddha |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Santorium kancheepuram Chennai 600047
Kancheepuram
TAMIL NADU |
6374290636
22381314
dharshiniselvarasu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
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 |
Milaghu Legiyam(Internal) and Kunthiriga thailam (External) |
Milaghu Legiyam (Internal) 6gms Bd with Milk for 48 days
Kunthiriga thailam (External) external application for 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Low back pain radiating to lower limb posterolaterally
Numbness and paresthesia in same distribution
Low back ache aggrevates after prolonged standing and walking
Difficulty in bending and lifting
Coughing exacerbates the low back pain etc
(Any 2 or more symptoms will be included)
2.Positive SLR Test
3.Positive Lasegue Test
4.The Modified Oswestry Disability Scale a score of 40% or more will be taken
5.Patient willing to undergo radiological investigation and laboratory investigation
6.Patient willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled Diabetes Mellitus
2.Ankylosis Spondylosis
3.Vertebral fracture and Spinal deformity
4.Cardiac and renal diseases
5.Pregnant and Lactating mother
6.with severe and terminal illness like CA or HIV
7.Not willing to give blood samples for investigation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the Modified Oswestry Low Back Disability Status of the patient before & after the treatment will be obtained
2.Reduction in pain is assesed by using the universal Pain Assesment Scale |
18 MONTHS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
26/08/2023 |
| 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 Applicable |
| 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
|
INTRODUCTION: This is an open clinical trial that evaluates therapeutic effectiveness of siddha formulation MILAGHU LEGHIYAM AND KUNTHIRIGA THAILAM in the management of VATHASTHAMBAM (SCIATICA) patients through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment. Sciatica is a condition characterized by pain affecting the low back, hip and outer side of the leg, caused by compression of a spinal nerve root in the lower back, often owing to degeneration of an inter - vertebral disc. 5%-10% of patients with low back pain have sciatica, whereas the reported lifetime prevalence of low back pain ranges from 49% to 70%. The annual prevalence of disc related sciatica in the general population is estimated at 2.2%. OBJECTIVE: PRIMARY OBJECTIVE: • To assess the therapeutic effectiveness of MILAGHU LEGHIYAM (INTERNAL) and KUNTHIRIKA THAILAM (EXTERNAL) in the management of VATHASTHAMABAM through The Modified Oswestry Low Back Disability Questionnaire and Universal Pain Assessment Scale before and after treatment. • To evaluate the standardization of the trial drug Milaghu leghiyam and Kunthiriga thailam SECONDARY OBJECTIVE: • To evaluate the laboratory parameters before and after the study. MATERIALS AND METHODS: A Total of 30 diagnosed patients of Vathasthambam (Sciatica) within the age limit of 20-60 years willing to participate in the study, by signing the consent form will be enrolled in the study. Uncontrolled Diabetes Mellitus, K/H/O Ankylosing spondylitis, K/H/O Vertebral fracture and Spinal deformity, Cardiac diseases and Renal diseases, Pregnant and lactating women and With severe or terminal illness like CA or HIV, Not willing to sign the informed consent will be excluded. Assessment is done through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment. RESULTS AND DISCUSSION: The result will be statistically analyzed KEYWORDS : Vathasthambam, Sciatica, Milaghu Legiyam |