| CTRI Number |
CTRI/2026/01/100851 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of BBETTER SpineUrja for Lower Back Pain |
|
Scientific Title of Study
|
Efficacy and Safety of BBETTER SpineUrja in Managing Lower Back Pain and Sciatica: A Randomized, Double-Blind, Placebo-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBETTER/Spine/Urja/25/03, Version 1.0; dt. 25th Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MONKSAYS SUPERFOODS PVT. LYD. |
|
|
Primary Sponsor
|
| Name |
MONKSAYS SUPERFOODS PVT. LYD. |
| Address |
Plot no. 31, Sagar Society, Rd. no. 2, Banjara Hills,
Hyderabad, Telangana- 500034, India.
|
| Type of Sponsor |
Other [Private Limited Company (Nutraceutical / Wellness Products 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 Sanjeev Kumar Kare |
Government Medical College & Govt. General Hospital |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9912320517
08942-279000
drsanjeevkumarkare@yahoo.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 |
| Healthy Human Volunteers |
Lower Back Pain and Sciatica |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BBETTER SpineUrja Capsule 650 mg
|
One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks. |
| Comparator Agent |
Placebo Capsule |
One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 30 to 65 years.
2. Chronic lower back pain or sciatica for at least 3 months.
3. Pain intensity score between 4 and 7 on the Visual Analog Scale (VAS).
4. Willingness to adhere to study guidelines and avoid additional spine-related medications or treatments.
5. Ambulatory and capable of performing basic physical activities.
6. Willingness to discontinue other joint health supplements or anti-inflammatory medications (except rescue acetaminophen).
7. No significant comorbidities or surgeries in the past 6 months.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline. |
Baseline, Week 4, Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in spinal mobility and function improvement using Oswestry Disability Index (ODI) scores from baseline. |
Baseline, Week 4, Week 8 |
| Change in spinal mobility and function improvement using Roland-Morris Disability Questionnaire (RMD) scores from baseline. |
Baseline, Week 4, Week 8 |
| Change in Short Form-12 (SF-12) for Quality of Life score from baseline. |
Baseline, Week 4, Week 8 |
| Change in Systemic Inflammatory Biomarkers (IL-6, CRP) from baseline. |
Baseline, Week 8 |
| Change in laboratory values for liver parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) from baseline. |
Baseline, Week 8 |
| Change in laboratory values for kidney parameters (serum creatinine, blood urea nitrogen) from baseline. |
Baseline, Week 8 |
| Change in Treatment-Emergent Adverse Events (TEAEs) from baseline. |
Baseline, Week 4, Week 8 |
| Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline. |
Baseline, Week 4, Week 8 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| 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="0"
Months="2"
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
|
This study is designed to evaluate the efficacy and safety of BBETTER SpineUrja in adults with mild to moderate lower back pain and sciatica. The study will be conducted as a randomized double blind placebo controlled clinical trial. Eligible participants aged 30 to 65 years will be randomly assigned to receive either BBETTER SpineUrja capsules or placebo capsules twice daily for a duration of eight weeks.
The primary objective of the study is to assess the effect of BBETTER SpineUrja on pain intensity using the Visual Analog Scale. Secondary objectives include evaluation of functional disability spinal mobility and quality of life using validated tools such as the Oswestry Disability Index Roland Morris Disability Questionnaire and Short Form 12. Safety will be assessed through monitoring of adverse events vital signs and laboratory investigations including inflammatory biomarkers and liver and kidney function parameters.
The hypothesis of this study is that BBETTER SpineUrja will significantly reduce lower back pain and sciatica symptoms improve functional outcomes and enhance quality of life compared to placebo while being safe and well tolerated. |