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A clinical trial to study the treatment effectiveness of oral beta-sitosterol in female overactive bladder

Efficacy of beta sitosterol in female overactive bladder

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035249
Enrollment
45
Registered
2021-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N328- Other specified disorders of bladder

Interventions

Intervention1: Beta-sitosterol: Oral capsule 60 mg thrice daily 30 minutes before food and Behavioral therapy for 12 weeks to 15 patients. Pure encapsulations Beta sitosterol, 60 mg non-GMO (genetical

Sponsors

Prof Manidip Pal
Lead Sponsor
Prof Priyadarshi De for urinary molecular study
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult female with OAB symptoms (frequency, urgency, nocturia with or without urgency incontinence.)

Exclusion criteria

Exclusion criteria: Any UTI, cancer, neurologic disease, space occupying lesion in pelvis, hypertension, angioedema, asthma, chronic ulcerative stomatitis, bladder outlet obstruction, patient on digoxin, drugs metabolized by CYP2D6 (e.g. metoprolol, desipramine), history of overreaction to NSAIDs, pregnancy, lactation etc.

Design outcomes

Primary

MeasureTime frame
Changes in OABSS (Overactive bladder symptom score), PGI-I score (Patient global impression of improvement), changes in urinary molecular study of MCP-1 (Monocyte chemoattractant protein 1), BDNF (Brain derived neurotrophic factor), NGF (Nerve growth factor) normalised with urinary creatinine levels, urinary iNOS (inducible nitric oxide synthase)Timepoint: at 12 weeks follow-up visit

Secondary

MeasureTime frame
OABSS (Overactive bladder symptom score) and PGI-I score (Patient Global Impression of improvement)Timepoint: OABSS at 2 weeks and 6 weeks follow-up visit PGI-I at 6 weeks follow-up visit

Countries

India

Contacts

Public ContactDr Manidip Pal

College of Medicine and JNM Hospital, WBUHS

manideep2b@yahoo.com9051678490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026