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Effectiveness of BBETTER SpineUrja for Lower Back Pain

Efficacy and Safety of BBETTER SpineUrja in Managing Lower Back Pain and Sciatica: A Randomized, Double-Blind, Placebo-Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100851
Enrollment
70
Registered
2026-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BBETTER SpineUrja Capsule 650 mg : One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks. Control Intervention1: Placebo Capsule: One capsule

Sponsors

MONKSAYS SUPERFOODS PVT. LYD.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline.Timepoint: Baseline, Week 4, Week 8—

Secondary

MeasureTime frame
Change in spinal mobility and function improvement using Oswestry Disability Index (ODI) scores from baseline.Timepoint: Baseline, Week 4, Week 8;Change in spinal mobility and function improvement using Roland-Morris Disability Questionnaire (RMD) scores from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Short Form-12 (SF-12) for Quality of Life score from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Systemic Inflammatory Biomarkers (IL-6, CRP) from baseline.Timepoint: Baseline, Week 8;Change in laboratory values for liver parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) from baseline.Timepoint: Baseline, Week 8;Change in laboratory values for kidney parameters (serum creatinine, blood urea nitrogen) from baseline.Timepoint: Baseline, Week 8;Change in Treatment-Emergent Adverse Events (TEAEs) from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline.Timepoint: Baseline, Week 4, Week 8—

Countries

India

Contacts

Public ContactDr Sanjeev Kumar Kare

Government Medical College & Govt. General Hospital

drsanjeevkumarkare@yahoo.com9912320517

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026