| CTRI Number |
CTRI/2025/08/092460 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to understand the effectiveness and safety of a product in adults with very bad back pain where the pain can be felt going down either to one or both legs. |
|
Scientific Title of Study
|
An open label, single centric, single arm study to evaluate the efficacy and safety of WELLPEA® for the management of chronic back pain with sciatica in adults population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GLI_SCRS_PEA_2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith N |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital and Research Center |
| Address |
Rajalakshmi Hospital and Research Center,
Department of Orthopaedic,
Ground Floor, Room Number-2,
No.21/1, Lakshmipura Main Road, Vidyaranyapura Post
Bangalore
KARNATAKA
560097
India |
| Phone |
9844141315 |
| Fax |
|
| Email |
harshithortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd |
| Address |
Manidweep, 3rd Floor, C-2, No.13,
Dynasty Layout Mariannapalya,
H.A. Farm (post), Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9972598010 |
| Fax |
|
| Email |
deepa@syncretic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd |
| Address |
Manidweep, 3rd Floor, C-2, No.13,
Dynasty Layout Mariannapalya,
H.A. Farm (post), Hebbal
KARNATAKA
560024
India |
| Phone |
9972598010 |
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
| GIELLEPI S.p.A,
Via G. Verdi 41Q, 20831 Seregno (MB),
ITALY |
|
|
Primary Sponsor
|
| Name |
GIELLEPI S.p.A |
| Address |
Via G. Verdi 41Q, 20831
Seregno (MB), ITALY |
| Type of Sponsor |
Other [[Manufacturer, Limited Company] ] |
|
|
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 Harshith N |
Rajalakshmi Hospital and Research Centre |
Department of Orthopedics,
Room number-2, Ground Floor,
No.21/1.,
Lakshmipura Main Road,
Vidyaranyapura
Bangalore
KARNATAKA |
9844141315
harshithortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital 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 |
Not Applicable |
Not Applicable |
| Intervention |
WELLPEA® |
1 sachet to be mixed in one glass of water till fully dissolved and has to be taken orally immediately after food once a day in the morning. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male or female subjects (age 18-65 yrs).
2.Subjects diagnosed with chronic (lasting for atleast 3 months) lower back pain due to sciatica.
3.Radiating pain into one leg below the knee.
4.Pain score between 4 - 6 on Numerical rating score (NRS).
5.DN4 score more than 4.
6.Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
7.Patient should be able to give written informed consent prior to participating in the study. |
|
| ExclusionCriteria |
| Details |
1.Any serious spinal pathology (e.g. cauda equina syndrome, spinal fracture).
2.Spinal surgery or interventional procedures scheduled for sciatica during the 4 week treatment period.
3.On a medication for neuropathic pain, a tricyclic antidepressant or a sedative and unable to cease the medication.
4.Subjects taking nutraceuticals containing PEA, alpha lipoic acids, botanical extracts and other functional ingredients able to reduce LBP and/or intefearing with the Endocannabinoid system.
5.Steroidal anti-inflammatory drugs, NSAIDs during the month prior to screening.
6.Any fractures as well as muscle sprain.
7.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases, infections).
8. High alcohol intake (more than 2 drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana etc).
9.Subjects with known sensitivity to any components of the investigational product.
10.Pregnant or breastfeeding women, and males or females planning conception during the 4 week treatment period.
11.Participation in concomitant interventional clinical study or during the previous 30 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Reduction of pain (NRS less than 4) in atleast 50% of subjects.
•Change in pain using NRS.
•Change in pain using NPS.
•Change in Daily life disability by Oswestry Disability Index (ODI).
•Change in DN4. |
Screening, Week 1,2,3 & 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical Examination
2.Vital Signs: Pulse rate, blood pressure & body temperature
3.Lab assessment
4.Adverse Event Assessments |
Screening, Week 1,2,3 & 4. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
09/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is an open label study. This study will be conducted in a single clinical site, Institutional Ethics committee of which, is registered with CDSCO. Study will be only initiated after receiving CTRI registration number. This study is to assess the efficacy and safety of investigational product in subjects diagnosed with chronic back pain with sciatica. . After satisfying all the inclusion/exclusion criteria they will be included in the study. On Day 0 they will be dispensed with the medication and visit plan will be provided.
Study population - 60 subjects. Study duration - 4 weeks from baseline. Visits - 6 visits.
Study Outcomes;
Primary outcome - Reduction of pain (NRS less than 4) in at least 50% of subject.
Secondary outcome - Change in pain using NRS and NPS, Change in ODI, Change in DN4.
Type of study- Open Label |