| CTRI Number |
CTRI/2024/03/064253 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Siddha formulations Nuflm-1 capsule, Spln-2 softgel and Rudn oil-3 in the treatment of neck pain and backpain with sciatica. |
|
Scientific Title of Study
|
A pilot clinical trial to determine the safety and effectiveness of coded Siddha
formulations Nuflm-1 capsule, Spln -2 softgel and Rudn oil -3 in the management
of cervical disc disorder with radiculopathy (M50.10) and Sciatica (M54.3) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr G J Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr G J Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ramamurthy |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9443178112 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| PROF DR G J CHRISTIAN |
Ayothidoss Pandithar Hospital |
Teaching block 2
Department of NoiNaadal
National institute of Siddha
Tambaram sanatorium
TAMIL NADU
Chennai
TAMIL NADU |
9962545930
christianvijila@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: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Nuflm-1 capsule Spln – 2 softgel Rudn oil – 3 |
Nuflm-1 capsule 500mg capsule twice a day for 24 days Spln – 2 softgel 2 caps thrice a day for 48 days Rudn oil – 3 external application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Males or females, ages 18 to 65, are able and willing to provide written informed consent to participate in the study.
Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment.
Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 3 days period) of at least 4 in the numerical rating scale. Leg pain should be more severe than back pain on Numerical rating scale of pain at screening.
Positive straight leg raising (SLR) test.
Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for less than 3 months.
At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motoneuron lesion to the upper-limb.
Positive responses to at least 3 of the 4 following clinical tests: Spurling Test, Upper
Limb Tension Test, Cervical Distraction Test, and less than 60° of cervical rotation
on the impaired side.
|
|
| ExclusionCriteria |
| Details |
Known or suspected serious spinal pathology.
Prior surgery to the cervico - thoracic spine.
Signs of superior motor neuron impairments.
Cervical spine injection in the previous four weeks.
Current use of steroidal anti-inflammatory drugs.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Score reduction in Roland Morris Disability Questionnaire, Aberdeen Low Back Pain Scale and neck disability index score from baseline to end of the treatment.
2. Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status
3. Laboratory parameters to assess the drug safety will be done weekly for two patients who receive the Nuflm-1 capsule along with Spln – 2 softgel and Rudn oil - 3. For other 8 patients baseline and endpoint measurements |
48 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
26/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
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
|
Neck pain (NP) and low back pain (LBP) are common symptoms bothering people in daily life. Conventional treatments, such as medications and surgery, have demonstrated some efficacy. Nonetheless, these treatments were not always effective, and even had some serious adverse effects. Consequently, to find some more effective therapeutic methods, many individuals have turned their attention to some other treatments, such as complementary and alternative medicine. This pilot study involving 10 participants, is put forward to assess the efficacy of proposed orally administered Siddha proprietary medicine combinations such as Nuflm-1 capsule, Spln – 2 softgel and external Rudn oil – 3 in the management of cervical and lumbosacral neuralgia. The drugs contained in the proposed proprietary formulation medicine Nuflm-1 capsule includes Amukkura churanam, Thiripala churanam, Pirandai uppu, Panchapadana chenduram, Arumuga chenduram, Thamira (Sembu) parpam and Sangu Parpam. All the components have property of alleviating different neuralgic conditions. |