FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086126 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Research to investigate the safety and effect of Siddha herbo-mineral drugs in managing long term neck and back neurological pain. 
Scientific Title of Study   Proof of concept clinical trial to determine the safety and efficacy of Siddha pharmacotherapy with coded drugs in Chronic Cervical disc disorder with radiculopathy and Chronic Sciatica 
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 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  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  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 600047 Tamil Nadu India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G J CHRISTIAN  Ayothidoss Pandithar Hospital, National Institute of Siddha  OPD and IPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, GST road, National Institute of Siddha, Tambaram Sanatorium, Chennai, 600047
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Nuflm 1 Spln 2 Rudn oil 3   A.Nuflm 1 - capsule :500mg capsule Dose 1 capsule (500mg) bid for patients who are less than 50 kg of body weight. 2 capsules (1gm) bid for patients who are more than 50 kg of body weight. Duration: 60 days (24 days drugging – 12 days drug holiday – 24 days drugging) B. Spln 2 - plain/softgel capsule 0.75 ml of Vatha Ennai (Anjennai thailam) 38,39 Dose:3 capsules, bid; Or 0.75 ml of vatha ennai Duration: 60 Days Rudn oil 3 External application only over the spine and limbs  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria: (For Sciatica)
Males or females, ages 18 to 65, 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 through MRI, the onset of which occurred at least 3 months 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.
Inclusion Criteria: (For Cervical Radiculopathy)
Males or females, ages 18 to 65, able and willing to provide written informed consent to participate in the study.
Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for at least 3 months.
At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motor neuron 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  Exclusion Criteria: (For Sciatica)
Known or suspected serious spinal pathology (fracture; malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder).
Suspected or confirmed pregnancy or less than six months post partum or planning for pregnancy.
Spinal surgery greater than 12 months previously; scheduled for major surgery during the treatment or follow up period.
Uncontrolled mental health condition that precludes successful participation.
Inclusion Criteria: (For Cervical Radiculopathy)
Males or females, ages 18 to 65, able and willing to provide written informed consent to participate in the study.
Pain, paresthesia or numbness in the upper limb with cervical or periscapular pain for at least 3 months.
At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motor neuron 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 degree of cervical rotation on the impaired side.
Exclusion Criteria: (For Cervical Radiculopathy)
Prior surgery to the cervico thoracic spine.
Signs of superior motor neuron impairments (bilateral paresthesia, hyperreflexia, spasticity).
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.   Baseline- Day 1
Week 3
Week 5
Week 7
Week 9 
 
Secondary Outcome  
Outcome  TimePoints 
Score reduction in Roland Morris Disability Questionnaire, Aberdeen Low Back Pain Scale, Oswestry Disability index, Sciatica Bothersome Index, Medical outcome study Short Form 36 physical components score, Cervical Radiculopathy Impact Scale, Patient-Specific Functional Scale, Global Perceived Effect Scale and Neck disability index score from baseline to end of the treatment.
Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status.
Laboratory parameters to assess the drug safety will be done before and after treatment for all the patients who receive the Nuflm-1 capsule along with Spln – 2 plain/softgel and Rudn oil - For patients baseline and endpoint measurements of the above parameters will be done on the screening day and 60th day.
 		 Baseline- Day 1
Week 3
Week 5
Week 7
Week 9 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   22/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Neck pain (NP) and low back pain (LBP) are common symptoms bothering people in daily life. These two disorders occur most frequently among the middle-aged population, in which the proportion of females is higher than that of males 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 study is put forward to assess the efficacy of proposed orally administered Siddha proprietary medicine combination as Nuflm-1 capsule, Spln – 2 plain/softgel and external Rudn oil – 3 in the management of Chronic cervical disc disorder with radiculopathy (M50.10) and Chronic Sciatica (M54.3).
Aim
To determine the Safety and effectiveness of proposed Siddha proprietary formulations Nuflm-1 capsule, Spln – 2 plain/softgels and Rudn oil – 3 (external) in management of Chronic cervical disc disorder with radiculopathy (M50.10) and Chronic Sciatica (M54.3)
Objectives
Primary Objective
To evaluate the safety and therapeutic effectiveness of proposed Siddha proprietary formulations Nuflm-1 capsule, Spln – 2 plain/softgels and Rudn oil – 3 (external) in the management of Chronic cervical disc disorder with radiculopathy (M50.10) and Chronic Sciatica (M54.3) through a subject-rated NRS (Numerical Rating Scale). The NRS is a continuous measure that ranges from 0 (no pain) to 10 (worst pain imaginable).
Secondary objectives
To compare the improvement in the degree of disability and pain using the Roland-Morris Disability Questionnaire (RMDQ), Sciatica Bothersome Index, Medical outcome study Short Form 36 physical components score, Oswestry Disability index, Aberdeen Low Back Pain Scale, Straight leg raising test, Neck Disability Index Score, Cervical Radiculopathy Impact Scale, Patient-Specific Functional Scale and Global Perceived Effect Scale. 
To assess quality of life (QoL) through EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) scale.
To observe the safety of trial drugs assessed through lab investigations and to document the adverse effects if any.
Methods
Participants and Outcomes
Study type: Experimental study
Study design: Open label - single arm - Clinical Trial
Study Setting:
Study will be conducted in OPD & IPD of Ayodhidoss Pandithar Hospital,
National Institute of Siddha, 
Tambaram Sanatorium, 
Chennai -47
Sample Size
25 patients (Chronic Cervical Radiculopathy)
25 patients (Chronic Sciatica)
Study period: 2 years
Criteria for participant selection
Participants
Patients reporting at the NIS OPD with complaints of neck and shoulder pain or back and leg pain will be screened to determine whether they meet the following inclusion and exclusion criteria and given the option to take part in the clinical trial
Inclusion Criteria: (For Sciatica)
Males or females, ages 18 to 65, 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 through MRI, the onset of which occurred at least 3 months 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.  
Exclusion Criteria: (For Sciatica)
Known or suspected serious spinal pathology (fracture; malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder). 
Suspected or confirmed pregnancy or less than six months post-partum or planning for pregnancy. 
Spinal surgery < 12 months previously; scheduled for major surgery during the treatment or follow-up period.
Uncontrolled mental health condition that precludes successful participation.
Inclusion Criteria: (For Cervical Radiculopathy)
Males or females, ages 18 to 65, able and willing to provide written informed consent to participate in the study.
Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for at least 3 months.
At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motor neuron 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.  
Exclusion Criteria: (For Cervical Radiculopathy)
Prior surgery to the cervico - thoracic spine. 
Signs of superior motor neuron impairments (bilateral paresthesia, hyperreflexia, spasticity). 
Cervical spine injection in the previous four weeks.
Current use of steroidal anti-inflammatory drugs.
Intervention
A.Nuflm 1 - capsule :500mg capsule 
Dose
1 capsule (500mg) bid for patients who are less than 50 kg of body weight.
2 capsules (1gm) bid for patients who are more than 50 kg of body weight.
Duration: 60 days (24 days drugging – 12 days drug holiday – 24 days drugging)
B. Spln 2 - plain/softgel capsule
0.75 ml of Vatha Ennai (Anjennai thailam) 38,39
Dose:3 capsules, bid; Or 0.75 ml of vatha ennai
Duration: 60 Days
Rudn oil 3          
External application only over the spine and limbs 
Outcomes
Primary Outcome
Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment. 
Secondary Outcome
Score reduction in Roland Morris Disability Questionnaire, Aberdeen   Low Back Pain Scale, Oswestry Disability index, Sciatica Bothersome Index, Medical outcome study Short Form 36 physical components score, Cervical Radiculopathy Impact Scale, Patient-Specific Functional Scale, Global Perceived Effect Scale and Neck disability index score from baseline to end of the treatment.  
Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status. 
Laboratory parameters to assess the drug safety will be done before and after treatment for all the patients who receive the Nuflm-1 capsule along with Spln – 2 plain/softgel and Rudn oil - 3. For patients baseline and endpoint measurements of the above parameters will be done on the screening day and 60th day. 

 
Close